Osteoporosis, Osteoporosis, Postmenopausal
Conditions
Brief summary
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. This study will help us determine the optimal duration and 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.
Interventions
DRUGdenosumab
denosumab 60 milligrams subcutaneously every 6 months
DRUGalendronate
alendronate 70 milligrams weekly
DRUGraloxifene
raloxifene 60 milligrams daily
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum c-telopeptide (CTX) | Month 12 to 18 months | Change in serum CTX between month 12 and month 18 |
| Bone mineral density (BMD) | Month 24 to 36 months | Change in PA spine BMD between month 24 and month 36 |
Countries
United States
Outcome results
None listed