Trial Outcomes & Findings for Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma (NCT NCT00301873)

Last Updated: 2013-02-18

Results Overview

Percent of patients who failed treatment as defined by a decrease of 0.5 or more from baseline in the combined T-score as measured by Dexa-scan. The patient's bone densitometry was determined by Dexa-scan at baseline, after 6 months of Zometa and after 1 year of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year-old of the same sex, was generated by Dexa-scan for the spine and femur. The combined T-score is the minimum of the T-score for the spine and femur. A lower t-score implies a lower BMD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

6 and 12 months

Results posted on

2013-02-18

Participant Flow

Patients were accrued between February 2006 and January 2008 within the clinic at Duke Comprehensive Cancer Center.

Participant milestones

Participant milestones
Measure	IV Zometa Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Overall Study STARTED	59
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Zometa n=59 Participants Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=39 Participants
Age, Categorical >=65 years	10 Participants n=39 Participants
Age Continuous	54.7 years STANDARD_DEVIATION 9.4 • n=39 Participants
Sex: Female, Male Female	21 Participants n=39 Participants
Sex: Female, Male Male	38 Participants n=39 Participants
Anticonvulsant use yes	54 participants n=39 Participants
Anticonvulsant use no	5 participants n=39 Participants
Steroid use yes	41 participants n=39 Participants
Steroid use no	18 participants n=39 Participants

PRIMARY outcome

Timeframe: 6 and 12 months

Population: 59 patients were accrued; however only 27 had a follow-up assessment at 6 months and 19 at 12 months.

Outcome measures

Outcome measures
Measure	IV Zometa n=59 Participants Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5. At 6 months (n=27)	3.7 percentage of patients
Percent of Patients With Change in Combined Bone Mass Density T-score <= -0.5. At 12 months (n=19)	10.5 percentage of patients

SECONDARY outcome

Timeframe: 1 year

Population: All patients.

Number of patients who experience skeletal-related complications during the administration of Zoledronate.

Outcome measures

Outcome measures
Measure	IV Zometa n=59 Participants Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Skeletal-related Complications	0 participants

SECONDARY outcome

Timeframe: 6 & 12 months

Population: 59 patients were accrued to the study; however follow-up at 6 months was available from 27 patients and at 12 months data was available from 19 patients.

Mean change in the combined t-score was measured by Dexa-scan. The patients bone density was determined by Dexa-scan at baseline, after 6 months Zometa and after 12 months of Zometa. The t-score, which is a comparison of a person's bone density with that of a healthy 30-year old of the same sex, was generated by Dexa-scan for the spine and femur. A lower t-score implies a lower BMD. The combined t-score is the minimum of the t-score for the spine and that for the femur. BMD change from baseline at 6 and 12 months in the combined t-score was defined as the follow-up combined t-score minus the baseline combined t-score.

Outcome measures

Outcome measures
Measure	IV Zometa n=59 Participants Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
Mean Change in Bone Mass Density (BMD) Change in combined BMD at 6 months (n=27)	.01 T score units Standard Deviation .21
Mean Change in Bone Mass Density (BMD) Change in combined BMD at 12 months (n=19)	-.06 T score units Standard Deviation .31

Adverse Events

IV Zometa

Serious events: 16 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IV Zometa n=59 participants at risk Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
General disorders fever	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Skin and subcutaneous tissue disorders Skin ulceration	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Metabolism and nutrition disorders dehydration	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Gastrointestinal disorders diarrhea	3.4% 2/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Intracranial hemorrhage	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Infections and infestations infections and infestations-other	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Infections and infestations Skin infection	3.4% 2/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Infections and infestations Urinary tract infection	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Infections and infestations Device related infection	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Peripheral motor neuropathy	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Facial nerve disorder	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders seizure	6.8% 4/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Depressed level of consciousness	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders headache	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Vascular disorders phlebitis	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Vascular disorders thrombo embolic event	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Injury, poisoning and procedural complications Vascular access complication	3.4% 2/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Investigations Neutrophil count decreased	1.7% 1/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.

Other adverse events

Other adverse events
Measure	IV Zometa n=59 participants at risk Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
General disorders fatigue	23.7% 14/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
General disorders fever	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Psychiatric disorders insomnia	11.9% 7/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Skin and subcutaneous tissue disorders rash maculo-papular	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Metabolism and nutrition disorders anorexia	6.8% 4/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Gastrointestinal disorders constipation	13.6% 8/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Gastrointestinal disorders diarrhea	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.9% 7/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders ataxia	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders cognitive disturbance	10.2% 6/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Psychiatric disorders confusion	16.9% 10/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders dizziness	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders memory impairment	18.6% 11/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Psychiatric disorders mood alteration	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Peripheral motor neuropathy	13.6% 8/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Peripheral sensory neuropathy	6.8% 4/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders seizure	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders Depressed level of consciousness	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders dysphasia	13.6% 8/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Eye disorders blurred vision	5.1% 3/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Nervous system disorders headache	15.3% 9/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Musculoskeletal and connective tissue disorders arthralgia	8.5% 5/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Renal and urinary disorders urinary incontinence	6.8% 4/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.
Renal and urinary disorders erectile dysfunction	11.9% 7/59 • All Adverse Events regardless of grade over a period of 1 year Common Terminology for Adverse Events (CTCAE)3.0 used for collecting adverse events (AEs). Converted to 4.0 for this report. Serious Adverse Events(SAE): of the 16 pts affected by an SAE only, 3 were possibly, probably, or definitely related to Zometa. AEs: Of the 27 pts affected by an AE 12 were possibly, probably, or definitely related to Zometa.

Additional Information

Mary Lou Affronti, RN, MSN, ANP, MHSc Senior Investigator

Duke Comprehensive Cancer Center

Phone: 919-684-6239

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place