A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Status: | Completed |
---|---|
Conditions: | Osteoporosis, Osteoporosis, Postmenopausal Syndrome |
Therapuetic Areas: | Endocrinology, Rheumatology |
Healthy: | No |
Age Range: | 55 - 100 |
Updated: | 4/13/2017 |
Start Date: | May 2014 |
End Date: | July 2015 |
A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
This study will compare the effect of denosumab produced by two different manufacturing
processes on bone mineral density at the lumbar spine in postmenopausal women with
osteoporosis.
processes on bone mineral density at the lumbar spine in postmenopausal women with
osteoporosis.
Inclusion Criteria:
- Subject has provided informed consent prior to any study-specific
activities/procedures
- Ambulatory postmenopausal women.
- Age 55 years or older
- Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar
spine, total hip, or femoral neck.
Exclusion Criteria:
- Administration of osteoporosis treatments or bone active treatments within specific
timeframes
- Vitamin D deficiency
- Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism;
hypo/hyperthyroidism, unless stable and well-controlled)
- Contraindications to denosumab therapy (e.g., hypocalcemia)
We found this trial at
11
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials