Trial · Interventional
CompletedPhase 3Registry dataA Study of the Treatment of Postmenopausal Women With Osteoporosis
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 104 participants (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
China
- Start
- Jun 2003
- Primary completion
- Not stated
- Completion
- Aug 2004
- First posted
- 12 Oct 2007 (estimated)
- Last update posted
- 12 Oct 2007 (estimated)
- Conditions
- Osteoporosis, Post-Menopausal
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To compare the effect of treatment with teriparatide with that of salmon calcitonin in postmenopausal women with osteoporosis.
Interventions
- teriparatide 20 micrograms/day subcutaneousDrug
- salmon calcitonin 100 IU/day subcutaneousDrug
Arms2
Experimental
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 the effect of treatment with teriparatide 20 micrograms/day subcutaneous with that of salmon calcitonin 100 IU/day subcutaneous on change in lumbar spine BMD in postmenopausal women with established osteoporosis.
Secondary outcomes(3)
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in femoral neck and total hip BMD in postmenopausal women with established osteoporosis
to compare the effect of treatment with teriparatide 20 micrograms/day with that of calcitonin 100 IU/day on change in biochemical bone markers (bone specific alkaline phosphatase [BSAP] and Osteocalcin) at 3 and 6 months
to assess safety as determined by physical examination, vital signs, clinical laboratory data 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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