Postmenopausal Osteoporosis (PMO) Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
| Verified date | March 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
| Status | Completed |
| Enrollment | 252 |
| Est. completion date | June 17, 2015 |
| Est. primary completion date | October 9, 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 55 Years to 85 Years |
| Eligibility |
Inclusion Criteria: Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of = -4.00 at the lumbar spine or BMD T-score of = -3.50 at the total hip, or femoral neck) Exclusion Criteria: - Severe osteoporosis - Use of agents affecting bone metabolism - History of metabolic or bone disease (except osteoporosis) - Vitamin D insufficiency (vitamin D repletion and rescreening is permitted) - Current hyper- or hypocalcemia - Current, uncontrolled hyper- or hypothyroidism - Current, uncontrolled hyper- or hypoparathyroidism |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Anjyo-shi | Aichi |
| Japan | Research Site | Fukuoka-shi | Fukuoka |
| Japan | Research Site | Hachioji-shi | Tokyo |
| Japan | Research Site | Kita-adachi-gun | Saitama |
| Japan | Research Site | Kitakyushu-shi | Fukuoka |
| Japan | Research Site | Kiyose-shi | Tokyo |
| Japan | Research Site | Kyoto-shi | Kyoto |
| Japan | Research Site | Matsumoto-shi | Nagano |
| Japan | Research Site | Minato-ku | Tokyo |
| Japan | Research Site | Mizunami-shi | Gifu |
| Japan | Research Site | Morioka-shi | Iwate |
| Japan | Research Site | Osaka-shi | Osaka |
| Japan | Research Site | Ota-ku | Tokyo |
| Japan | Research Site | Saito-shi | Miyazaki |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sapporo-shi | Hokkaido |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Sendai-shi | Miyagi |
| Japan | Research Site | Shinagawa-ku | Tokyo |
| Japan | Research Site | Suginami-ku | Tokyo |
| Japan | Research Site | Takatsuki-shi | Osaka |
| Japan | Research Site | Toshima-ku | Tokyo |
| Japan | Research Site | Ueda-shi | Nagano |
| Japan | Research Site | Ueda-shi | Nagano |
| Japan | Research Site | Yanagawa-shi | Fukuoka |
| Japan | Research Site | Yokohama-shi | Kanagawa |
| Japan | Research Site | Yokohama-shi | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Japan,
Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine | Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 12 months | |
| Secondary | Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine | Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 6 months | |
| Secondary | Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip | Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 6 months | |
| Secondary | Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip | Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 12 months | |
| Secondary | Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck | Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 6 months | |
| Secondary | Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck | Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader. | Baseline and 12 months | |
| Secondary | Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | ||
| Secondary | Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | ||
| Secondary | Percent Change From Baseline in Osteocalcin | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | ||
| Secondary | Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | ||
| Secondary | Area Under the Curve Through Month 12 of P1NP | Baseline, week 1 and months 1, 2, 3, 6, 9, and 12. |