Bisphosphonates for Prevention of Post-Denosumab Bone Loss

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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 idiopathic osteoporosis (IOP) enrolled in AAAN0161 (FD05114) "Denosumab for the prevention of post-teriparatide bone loss in premenopausal women with idiopathic osteoporosis".

In addition, the investigator will observe participants for a second year off bisphosphonate therapy to assess duration of response.

The hypothesis is that bisphosphonate therapy with alendronate or zoledronic acid, initiated after recovery of bone remodeling activity, will prevent significant bone loss after discontinuing denosumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Amgen
• Treatments: Alendronate; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• Known intolerance to calcium supplements

• Contraindications to bisphosphonate treatment:

1. Hypocalcemia

2. Pregnancy

3. 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

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

2. Hypercalcemia, hypocalcemia

3. 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.