NCT03623633Active, not recruitingPhase 4
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Source: ClinicalTrials.gov · Last updated 7 Jun 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 6 Aug 2018
- Start date
- 30 Nov 2018
- Primary completion date
- 1 Feb 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Osteoporosis
- NCT number
- NCT03623633
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 51
- From 30 Nov 2018 to the primary completion date, 1 Feb 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- no significant previous use of bone health modifying treatments
- extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
Other illness
- known congenital or acquired bone disease other than osteoporosis
- significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- history of malignancy (except non-melanoma skin carcinoma)
Lab values
- abnormal calcium or parathyroid hormone level
- serum vitamin D \<20 ng/dL
Other
- hip fracture within one year of enrollment
- anemia (hematocrit \<32%)
- excessive alcohol use or substance abuse
- known contraindications to denosumab, alendronate, or raloxifene
Who the study is looking for
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines
Age in the registry: 45 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.