Trial · Interventional
CompletedPhase 3Registry dataComparison Medications in the Treatment of Postmenopausal Women With Osteoporosis
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 70 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
South Korea
- Start
- Aug 2003
- Primary completion
- Not stated
- Completion
- Nov 2004
- First posted
- 12 Oct 2007 (estimated)
- Last update posted
- 12 Oct 2007 (estimated)
- Conditions
- Osteoporosis, Postmenopausal
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis
NCT00542984Aug 2003 to Nov 2004
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.
Interventions
- teriparatide 20 micrograms/day subcutaneousDrug
- salmon calcitonin 100 IU/day subcutaneousDrug
Arms2
Active comparator
A
teriparatide 20 micrograms/day subcutaneous
Active comparator
B
salmon calcitonin 100 IU/day subcutaneous
Primary outcomes1
Outcomes the sponsor listed as primary.
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day subcutaneous with the effect of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD.
Secondary outcomes(3)
To compare in postmenopausal women with established osteoporosis the effect of treatment with teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in femoral neck and total hip BMD
Compare effect of teriparatide 20 micrograms/day with the effect of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase and Osteocalcin) at 3 and 6 months after treatment with teriparatide versus calcitonin.
Safety as determined by physical examinations, vital signs, clinical labs and reports of adverse events
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 55 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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