Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Osteoporosis Clinical Trial

Official title:

Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03623633
• Other study ID #: 2018P001612
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 30, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: August 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• denosumab
denosumab 60 milligrams subcutaneously every 6 months
• alendronate
alendronate 70 milligrams weekly
• raloxifene
raloxifene 60 milligrams daily

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum c-telopeptide (CTX)	Change in serum CTX between month 12 and month 18	Month 12 to 18 months
Primary	Bone mineral density (BMD)	Change in PA spine BMD between month 24 and month 36	Month 24 to 36 months