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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)

Information source: Nycomed
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Back Pain

Intervention: Parathyroid hormone (PTH) (1-84) (Drug); Alendronate (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Nycomed

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).

Clinical Details

Official title: A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 g PTH(1-84) Daily or 70 mg Alendronate Weekly

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.

Secondary outcome: Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Postmenopausal women with a T-score ≤ -1. 5 SD and at least one osteoporosis related

vertebral fracture. Chronic back pain. Exclusion Criteria:

- Previous/current treatment and medical history.

Locations and Contacts

Nycomed, Roskilde 4000, Denmark
Additional Information

Starting date: April 2008
Last updated: May 4, 2012

Page last updated: August 20, 2015

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