Phase 2
N=80
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Postmenopausal Osteoporosis · Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00086619 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Sep 2013
Primary outcome: Primary: Changes in Indices of Bone Turnover — 4418; 3696; 956; 822 months*(ng/ml - baseline ng/ml)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- synthetic hPTH 1-34 (Drug)
- Age
- Adult, Older Adult · 46+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Indices of Bone Turnover |
4418; 3696; 956; 822; 22; 19 | — |
| SECONDARY Change in Bone Mineral Density (BMD) |
-4.6; -3.1; 1.7; 3.5; 5.9; 7.4 | — |
Summary
Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.
Eligibility Criteria
Inclusion Criteria
- Three or more years after menopause
- Bone mineral density T-score 7 days in the past 12 months
- Use of bisphosphonates or fluoride
- Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count
- Elevated calcium levels in 24-hour urine collection
Data sourced from ClinicalTrials.gov (NCT00086619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.