Phase 2 Completed N=80 Randomized Treatment

Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women

Postmenopausal Osteoporosis · Osteoporosis

Source: ClinicalTrials.gov NCT00086619 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Sep 2013

Primary outcomePrimary: Changes in Indices of Bone Turnover — 4418; 3696; 956; 822 months*(ng/ml - baseline ng/ml)

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.