Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)
A 24-week, International, Multi Centre, Randomised, Open Label, Parallel Group, Phase IV Clinical Trial Investigating Changes in Bone Formation Markers in Postmenopausal Women With Primary Osteoporosis Treated With Either PTH(1-84) or Strontium Ranelate
2 other identifiers
interventional
82
1 country
1
Brief Summary
The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.
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 2007
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
June 28, 2011
CompletedMay 8, 2012
May 1, 2012
1.8 years
May 23, 2007
March 31, 2011
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen. Bone marker measurements were done by blood analysis.
Baseline and 24 weeks of treatment
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts. Bone marker measurements were done by blood analysis.
Baseline and 24 weeks of treatment
Secondary Outcomes (1)
Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
Baseline and 24 weeks of treatment
Study Arms (2)
PTH(1-84)
ACTIVE COMPARATORStrontium Ranelate
ACTIVE COMPARATORInterventions
Once daily subcutaneous injection in the abdomen by self administration
The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water
Eligibility Criteria
You may not qualify if:
- Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
- Is the subject female and at or above the age of 50?
- Has the subject been postmenopausal for more than 5 years - in the judgement of the investigator?
- Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only).
- Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia?
- Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for eligibility evaluation? \[\*\]
- Is the subject able to self-inject PTH(1-84), or get the injections by a helper?
- Has the subject:
- been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month?
- ever been treated with any bisphosphonate in intravenous form (i.v.)?
- been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months?
- been treated with fluoride for more than 3 months within the last 10 years?
- ever been treated with strontium ranelate?
- ever been treated with teriparatide or PTH(1-84)?
- received or is the subject currently receiving chronic glucocorticosteroid treatment?
- +20 more criteria
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
A limitation of the trial was the open label design, however this is not considered to affect the primary or secondary outcome of the trial.
Results Point of Contact
- Title
- Clinical Trial Operations
- Organization
- Nycomed
Study Officials
- STUDY CHAIR
Nycomed Clinical Trial Operations
Headquarters
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 25, 2007
Study Start
April 1, 2007
Primary Completion
February 1, 2009
Study Completion
July 1, 2009
Last Updated
May 8, 2012
Results First Posted
June 28, 2011
Record last verified: 2012-05