Status:
COMPLETED
Bisphosphonates for Prevention of Post-Denosumab Bone Loss
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Amgen
Conditions:
IOP
Osteoporosis
Eligibility:
FEMALE
20-55 years
Phase:
PHASE2
Brief Summary
The primary goal of the study is to assess the extent to which bisphosphonate therapy will prevent decreases in bone mass that may occur after cessation of denosumab in premenopausal women with idiopa...
Detailed Description
Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of \<200,000 affect...
Eligibility Criteria
Inclusion
- All women completing at least 12 months of Forteo treatment and at least 12 months of denosumab under previous research studies who remain without a diagnosis of an excluded medical condition and medication exposures as detailed below, will be offered enrollment into this study.
Exclusion
- Known intolerance to calcium supplements
- Contraindications to bisphosphonate treatment:
- Hypocalcemia
- Pregnancy
- Known hypersensitivity to bisphosphonates
- History of osteomalacia
- History of osteonecrosis of the jaw
- History of dental extraction or other invasive dental surgery within the prior 4 weeks
- Invasive dental work planned in the next 12 months
- Any condition or illness (acute, chronic, or history), which in the opinion of the Investigator might interfere with the evaluation of efficacy and safety during the study or may otherwise compromise the safety of the subject
- Self-reported or known alcohol or drug abuse within the previous 12 months
- Current or recent (within 1 year of enrollment) inflammatory bowel disease or malabsorption
- Abnormal laboratory tests performed during Visit 1
- Renal insufficiency or liver disease: estimated glomerular filtration rate (eGFR) \< 35 ml/min, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>50% above upper limit of normal
- Hypercalcemia, hypocalcemia
- Vitamin D deficiency: 25-Hydroxyvitamin D (25-OHD) \< 30 ng/mL
- Subjects must be willing to participate voluntarily. Specifically excluded are the following: 1) women less than 20 (or 35 in the case of those who wish to participate because they have low BMD); 2) protected individuals (institutionalized); 3) prisoners; 4) any other prospective participant who, for any reason, might not be able to give voluntary informed consent.
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03396315
Start Date
January 29 2018
End Date
June 9 2023
Last Update
May 8 2024
Active Locations (2)
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1
Creighton University
Omaha, Nebraska, United States, 68131
2
Columbia University Medical Center
New York, New York, United States, 10032