Comparative Antiresorptive Efficacy Discontinuation of Denosumab
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoporosis, Osteoporosis, Postmenopausal Syndrome |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 2/20/2019 |
| Start Date: | November 30, 2018 |
| End Date: | December 1, 2021 |
| Contact: | Natalie David, BA |
| Email: | ndavid2@mgh.harvard.edu |
| Phone: | 6177266129 |
Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Osteoporosis remains a significant healthcare burden for the United States. Current
FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates,
denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator
of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity
but bone turnover rapidly normalizes and bone turnover marker levels can rebound above
baseline levels after the drug is discontinued.
The proposed study will help us determine the relative efficacy of two oral antiresorptive
medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate
and raloxifene) in preventing the rebound increase in bone turnover that occurs after
denosumab discontinuation.
FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates,
denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator
of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity
but bone turnover rapidly normalizes and bone turnover marker levels can rebound above
baseline levels after the drug is discontinued.
The proposed study will help us determine the relative efficacy of two oral antiresorptive
medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate
and raloxifene) in preventing the rebound increase in bone turnover that occurs after
denosumab discontinuation.
Inclusion Criteria:
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture as per National Osteoporosis Foundation
guidelines
Exclusion Criteria:
- no significant previous use of bone health modifying treatments
- hip fracture within one year of enrollment
- known congenital or acquired bone disease other than osteoporosis
- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric
disease
- abnormal calcium or parathyroid hormone level
- serum vitamin D <20 ng/dL
- anemia (hematocrit <32%)
- history of malignancy (except non-melanoma skin carcinoma)
- excessive alcohol use or substance abuse
- extensive dental work involving extraction or dental implant within the past 6 months
or in the upcoming 12 months
- known contraindications to denosumab, alendronate, or raloxifene
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-2035
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