Phase 3
Completed N=362
A Study for Patients With Osteoporosis
Source: ClinicalTrials.gov NCT00414973 ↗Enrolled (actual)
362
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women — 6.04; 1.65 percentage change in lumbar spine BMD — p=<0.0001
Summary
The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women |
6.04; 1.65 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women |
-0.53; -0.62 | 0.9062 |
| SECONDARY Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women |
113.87; -7.67; 137.45; -10.58 | <0.0001 sig |
| SECONDARY Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men |
6.01; 3.38 | 0.2409 |
| SECONDARY Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men |
0.37; 1.34 | 0.6156 |
| SECONDARY Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men |
107.27; 4.35; 79.26; -17.65 | 0.0026 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of osteoporosis
- No other severe disabling conditions
- Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
- Ambulatory
- Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)
Exclusion Criteria
- History of a disease that affects bone metabolism
- History of treatment with any drug that may significantly affect bone metabolism
- History or presence of liver disease
- History or presence of kidney disease
- History of excessive alcohol drinking or drug abuse
Data sourced from ClinicalTrials.gov (NCT00414973). 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.