Phase 3
Completed N=207
Phase 3 Clinical Trial of Teriparatide in Japan
Source: ClinicalTrials.gov NCT00433160 ↗Enrolled (actual)
207
Serious AEs
9.5%
Results posted
Sep 2009
Primary outcomePrimary: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) — 9.82; 0.04 percent change in BMD — p=<0.001
Summary
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) |
9.82; 0.04 | <0.001 sig |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) |
10.23; 0.11 | — |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Total Hip |
2.66; -0.22 | — |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Femoral Neck |
2.24; 0.46 | — |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) |
90.67; -9.58; 89.58; -16.89; 114.12; -19.10 | <0.001 sig |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) |
3.74; -9.63; 3.23; -16.97; -4.60; -28.46 | <0.001 sig |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) |
2.78; -2.05; 46.52; -3.56; 82.27; 4.39 | 0.976 |
| SECONDARY Vertebral Fractures by Central X-ray Assessment |
7; 5; 3; 0 | — |
| SECONDARY Fractures by Investigators Assessment |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Back Pain Severity |
77; 36; 47; 26; 12; 4 | — |
| SECONDARY Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks |
11.93; 6.39; 13.42; 9.11 | — |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks |
12.24; 6.63; 14.01; 9.46 | — |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks |
3.02; 1.64; 3.67; 2.46 | — |
| SECONDARY Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks |
2.68; 1.17; 3.26; 2.19 | — |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks |
115.45; 97.28; 74.71; 134.89 | — |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks |
17.49; 15.71; -1.52; 16.45 | — |
| SECONDARY Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks |
85.85; 86.98; 54.39; 72.84 | — |
| SECONDARY Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks |
7; 7; 3; 3 | — |
| SECONDARY Fractures by Investigators Assessment During Entire Study Period of 104 Weeks |
0; 1; 0; 0; 1; 1 | — |
| SECONDARY Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks |
78; 38; 31; 13; 4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese patients diagnosed with osteoporosis
- Aged 55 or older
- Patients who are at high risk for fracture
Exclusion Criteria
- History of metabolic bone disorders other than primary osteoporosis
- History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
- Severe or chronically disabling conditions other than osteoporosis
Data sourced from ClinicalTrials.gov (NCT00433160). 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.