Phase 4
N=201
Preventing Osteoporosis Using Denosumab
Osteoporosis, Postmenopausal · Osteoporosis · Osteoporotic Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02753283 ↗Enrolled (actual)
201
Serious AEs
41.3%
Results posted
Sep 2024
Primary outcome: Primary: Bone Density of the Total Hip — 4.62; -0.19; 3.74; 0.48 Percent change — p=.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- denosumab (Drug); Placebo (Drug); Calcium and Vitamin D (Dietary_supplement)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Susan L. Greenspan
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Density of the Total Hip |
4.62; -0.19; 3.74; 0.48 | .007 sig |
| PRIMARY Bone Density of the Spine |
7.41; 2.15; 7.91; 1.12 | .014 sig |
| SECONDARY Distal Radius BMD |
2.030; -.376; 2.386; -1.115 | .060 |
| SECONDARY Femoral Neck BMD |
3.212; .185; 2.932; -.958 | .112 |
| SECONDARY TBS |
3.007; 1.099; 2.370; 3.318 | .904 |
Summary
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Eligibility Criteria
Inclusion Criteria
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) ages 65 and older will be considered if:
- Reside in long-term care institution (nursing home or assisted living facility); and
- HaveOsteoporosis: (1) by bone density [spine, hip or forearm Bone Mineral Density (BMD) T-score ≤ -2.5]; (2) A previous adult fragility fracture of the spine or hip; or (3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip fracture suing femoral neck BMD.
Exclusion Criteria
- Institutionalized residents with subacute illnesses who are not expected to survive or who will be discharged in 1year during the previous 2 years because some bisphosphonates are long acting.
- Those with a history of hypocalcemia or contraindication for treatment. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses.
- Those with vitamin D levels < 25ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more (if after 2 rounds of vitamin D repletion their vitamin D level is not at least 25 ng/mL, they will not be eligible to be randomized into the study).
- Those on dialysis or with stage 5 chronic kidney disease (eGFR<15ml/min) will be excluded at screening.
- Those requiring tooth extraction or oral surgery will not be enrolled until cleared by a dentist.
- Patients will be allowed to continue on glucocorticoids and anticonvulsants because their use is common in this population.
- Those on glucocorticoids and anticonvulsants will be allowed to continue in the study because their use is common in this population.
- Those on hormone replacement therapy (HRT), raloxifene, or prescribed protective hip pads by their Primary Care Physician (PCP) will be allowed to participate and continue on these therapies.
- We will suggest that participants stop long-term calcitonin as it has been discontinued in Europe due to cancer concerns.
Data sourced from ClinicalTrials.gov (NCT02753283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.