Trial Outcomes & Findings for Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy (NCT NCT01512446)
NCT ID: NCT01512446
Last Updated: 2019-02-12
Results Overview
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
436 participants
Primary outcome timeframe
From baseline to study termination (mean duration 5.6 months)
Results posted on
2019-02-12
Participant Flow
The study was early terminated due to a low recruitment rate
Participant milestones
| Measure |
Placebo
Placebo, administered orally once weekly
|
Alendronate
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Overall Study
STARTED
|
221
|
215
|
|
Overall Study
Safety Analysis Set
|
197
|
188
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
221
|
215
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=221 Participants
Placebo, administered orally once weekly
|
Alendronate
n=215 Participants
Alendronate 70 mg, administered orally once weekly
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.3 Years
STANDARD_DEVIATION 6.9 • n=99 Participants
|
74.3 Years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
74.8 Years
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
397 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
221 Participants
n=99 Participants
|
215 Participants
n=107 Participants
|
436 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to study termination (mean duration 5.6 months)Population: Full Analysis Set (all randomized participants)
Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.
Outcome measures
| Measure |
Placebo
n=221 Participants
Placebo, administered orally once weekly
|
Alendronate
n=215 Participants
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Number of New Osteoporotic Fractures
|
5 osteoporotic fractures
|
5 osteoporotic fractures
|
SECONDARY outcome
Timeframe: From baseline to study termination (mean duration 5.6 months)Population: Full Analysis Set (all randomized participants)
Number of deaths
Outcome measures
| Measure |
Placebo
n=221 Participants
Placebo, administered orally once weekly
|
Alendronate
n=215 Participants
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Mortality
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to study termination (mean duration 5.6 months)Population: Full Analysis Set (all randomized participants)
Number of participants with a new osteoporotic fracture or death
Outcome measures
| Measure |
Placebo
n=221 Participants
Placebo, administered orally once weekly
|
Alendronate
n=215 Participants
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Combination of New Osteoporotic Fractures and Deaths
|
7 Participants
|
5 Participants
|
Adverse Events
Placebo
Serious events: 38 serious events
Other events: 113 other events
Deaths: 0 deaths
Alendronate
Serious events: 31 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=197 participants at risk
Placebo, administered orally once weekly
|
Alendronate
n=188 participants at risk
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.51%
1/197
|
0.00%
0/188
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.51%
1/197
|
0.00%
0/188
|
|
Cardiac disorders
Acute coronary syndrome
|
0.51%
1/197
|
0.00%
0/188
|
|
Cardiac disorders
Cardiac failure
|
1.0%
2/197
|
0.53%
1/188
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/197
|
0.53%
1/188
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/197
|
0.53%
1/188
|
|
Endocrine disorders
Toxic nodular goitre
|
0.51%
1/197
|
0.00%
0/188
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
1/197
|
0.00%
0/188
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.0%
2/197
|
0.00%
0/188
|
|
Gastrointestinal disorders
Diverticulitis
|
0.51%
1/197
|
0.00%
0/188
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/197
|
0.53%
1/188
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/197
|
0.53%
1/188
|
|
Gastrointestinal disorders
Pancreas infection
|
0.51%
1/197
|
0.00%
0/188
|
|
General disorders
Impaired healing
|
0.51%
1/197
|
0.00%
0/188
|
|
General disorders
Pain
|
0.51%
1/197
|
0.00%
0/188
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Atypical femur fracture
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/197
|
1.1%
2/188
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Overdose
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.0%
2/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/197
|
0.53%
1/188
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.51%
1/197
|
0.00%
0/188
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/197
|
1.1%
2/188
|
|
Investigations
Catheterisation cardiac
|
0.51%
1/197
|
0.00%
0/188
|
|
Investigations
Hysteroscopy
|
0.00%
0/197
|
0.53%
1/188
|
|
Metabolism and nutrition disorders
Anaemia vitamin B12 deficiency
|
0.51%
1/197
|
0.00%
0/188
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.51%
1/197
|
0.53%
1/188
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.51%
1/197
|
0.00%
0/188
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/197
|
0.53%
1/188
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/197
|
0.53%
1/188
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
0.51%
1/197
|
0.00%
0/188
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.51%
1/197
|
0.00%
0/188
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.51%
1/197
|
0.00%
0/188
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.51%
1/197
|
0.00%
0/188
|
|
Nervous system disorders
Carotid artery stenosis
|
0.51%
1/197
|
0.00%
0/188
|
|
Nervous system disorders
Cerebellar infarction
|
0.51%
1/197
|
0.00%
0/188
|
|
Nervous system disorders
Syncope
|
0.51%
1/197
|
0.00%
0/188
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
1/197
|
1.1%
2/188
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/197
|
0.53%
1/188
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/197
|
0.53%
1/188
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/197
|
0.53%
1/188
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.51%
1/197
|
0.00%
0/188
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.51%
1/197
|
0.00%
0/188
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.51%
1/197
|
0.00%
0/188
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/197
|
0.53%
1/188
|
|
Surgical and medical procedures
Angioplasty
|
0.51%
1/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.51%
1/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Dupuytren's contracture operation
|
0.51%
1/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.51%
1/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Knee arthroplasty
|
1.0%
2/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.51%
1/197
|
0.00%
0/188
|
|
Surgical and medical procedures
Salpingo-oophorectomy
|
0.00%
0/197
|
1.1%
2/188
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/197
|
0.53%
1/188
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/197
|
0.53%
1/188
|
|
Surgical and medical procedures
Tooth extraction
|
0.51%
1/197
|
0.00%
0/188
|
|
Vascular disorders
Haematoma infection
|
0.51%
1/197
|
0.00%
0/188
|
|
Vascular disorders
Hypertension
|
0.51%
1/197
|
1.1%
2/188
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/197
|
0.53%
1/188
|
|
Nervous system disorders
Dizziness
|
0.00%
0/197
|
0.53%
1/188
|
Other adverse events
| Measure |
Placebo
n=197 participants at risk
Placebo, administered orally once weekly
|
Alendronate
n=188 participants at risk
Alendronate 70 mg, administered orally once weekly
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.7%
23/197
|
8.0%
15/188
|
|
Gastrointestinal disorders
Constipation
|
11.7%
23/197
|
5.9%
11/188
|
|
Gastrointestinal disorders
Tooth disorder
|
5.6%
11/197
|
4.8%
9/188
|
|
General disorders
Fatigue
|
15.2%
30/197
|
14.4%
27/188
|
|
General disorders
Hyperhidrosis
|
15.2%
30/197
|
11.2%
21/188
|
|
General disorders
Oedema peripheral
|
9.6%
19/197
|
7.4%
14/188
|
|
Infections and infestations
Upper respiratory tract infection
|
10.7%
21/197
|
6.4%
12/188
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
28.9%
57/197
|
23.4%
44/188
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
11/197
|
4.3%
8/188
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
19.8%
39/197
|
14.4%
27/188
|
|
Nervous system disorders
Dizziness
|
19.3%
38/197
|
11.7%
22/188
|
|
Nervous system disorders
Headache
|
11.2%
22/197
|
13.3%
25/188
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
24/197
|
7.4%
14/188
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.2%
28/197
|
7.4%
14/188
|
|
Skin and subcutaneous tissue disorders
Cutaneous symptom
|
10.7%
21/197
|
7.4%
14/188
|
|
Vascular disorders
Hypertension
|
11.7%
23/197
|
6.9%
13/188
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place