Study Stopped
Slow enrolment
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)
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 µg PTH(1-84) Daily or 70 mg Alendronate Weekly
1 other identifier
interventional
75
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 2, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
October 7, 2011
CompletedMay 8, 2012
May 1, 2012
2.1 years
July 2, 2008
July 28, 2011
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").
Baseline and 24 weeks treatment
Secondary Outcomes (1)
Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Baseline and 24 weeks treatment
Study Arms (2)
PTH (1-84)
ACTIVE COMPARATORPTH (1-84) + placebo alendronate
Alendronate
ACTIVE COMPARATORPTH (1-84) placebo + alendronate
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.
You may not qualify if:
- Previous/current treatment and medical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nycomedlead
Study Sites (1)
Nycomed
Roskilde, 4000, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small number of subjects analyzed.
Results Point of Contact
- Title
- Clinical Trial Operations
- Organization
- Nycomed
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2008
First Posted
July 11, 2008
Study Start
April 1, 2008
Primary Completion
May 1, 2010
Study Completion
September 1, 2010
Last Updated
May 8, 2012
Results First Posted
October 7, 2011
Record last verified: 2012-05