Trial · Interventional
CompletedPhase 2Registry dataA Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 217 participants (actual)
- Sponsor
- Shire · Industry
- Design
- Randomized · Triple masking
- Countries
2 countries
United States, Canada
- Start
- 18 May 1995
- Primary completion
- 24 Mar 1997
- Completion
- 24 Mar 1997
- First posted
- 15 Sept 2005 (estimated)
- Last update posted
- 17 May 2021
- Conditions
- Osteoporosis
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
A Study to Assess the Safety and Efficacy of 3 Doses of ALX1-11 (50, 75, and 100µg) in the Treatment of Postmenopausal Osteoporosis
NCT0017210718 May 1995 to 24 Mar 1997
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of 3 doses of ALX1-11 (recombinant human parathyroid hormone \[rhPTH(1-84)\])(50, 75 and 100 µg) in the treatment of postmenopausal osteoporosis. The primary objective of this study is to compare the efficacy of ALX1-11 (50, 75 and 100 µg) with that of placebo in terms of increasing vertebral bone mineral density, when given daily by subcutaneous injection for 12 months in postmenopausal women with osteoporosis.
Interventions
- ALX1-11 50 mcgDrug
- placeboDrug
- ALX1-11 75mcgDrug
- ALX1-11Drug
Arms4
Placebo comparator
1
Placebo drug injectable subcutaneously
Experimental
2
50 mcg PTH(1-84)
Experimental
3
75mcg PTH(1-84)
Experimental
4
100 mcg PTH(1-84)
Primary outcomes1
Outcomes the sponsor listed as primary.
Efficacy was assessed as percent change from baseline in BMD, BMC, and BMA at the lumbar spine, total hip, femoral neck and whole body (excluding the head) using DXA.
Time frame · 12 months of treatment
Secondary outcomes(1)
Secondary efficacy evaluations were also performed at Month 3, 6, and 12: Percent change from baseline in lumbar spine BMC and BMA; Percent change from baseline in total hip and femoral neck BMD, BMC and BMA
Time frame · 12 months
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 50 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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