CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
synthetic hPTH 1-34drug
Likely dose
hPTH(1-34) self-injected daily or in ascending doses at 6-month intervalsAI-extracted
Key inclusion· 2
  • ✓At least three years after menopause
  • ✓Bone mineral density T-score ≤−2.0 at lumbar spine or femoral neck (by DXA) or trabecular vertebral body (by QCT)
Key exclusion· 9
  • ✕Cannot walk without assistance
  • ✕Significant heart, kidney, liver, or malignant disease
  • ✕Current alcohol abuse
  • ✕Major psychiatric disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00086619
NCT00086619Phase 2Completed
CompareCT.gov

Evaluation of Factors That Affect Skeletal Responses to PTH

Massachusetts General Hospital·interventional·Posted Jul 8, 2004·Updated Oct 30, 2013

In Brief

A Phase 2 clinical trial evaluating synthetic hPTH 1-34 for Postmenopausal Osteoporosis and Osteoporosis. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis, Osteoporosis
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2004
Enrollment StartMay 1, 2004
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 22.0 years ago

Interventions

synthetic hPTH 1-34drug

Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34