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The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

NCT00713258 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-05-08

Study results available
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Summary

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Conditions

Interventions

DRUG

Parathyroid hormone (PTH) (1-84)

100 µg PTH(1-84) daily

DRUG

Alendronate

70 mg alendronate weekly

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2010-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00713258 on ClinicalTrials.gov