Preventing Osteoporosis Using Denosumab

NCT02753283 | Completed Phase 4 Results DMC

• 2 other identifiers: STUDY190502681R01AG052123-01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis, Postmenopausal; Osteoporosis; Osteoporotic Fractures

Keywords

Bone loss; Frail Geriatric Patients; Nursing Home Patients; Long-term Care Patients; Osteoporosis; Osteoporotic Fractures

Outcome Measures

Primary Outcomes (2)

• Bone Density of the Total Hip

  Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

  24 months

• Bone Density of the Spine

  Bone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

  24 months

Secondary Outcomes (3)

• Distal Radius BMD

  24 Months

• Femoral Neck BMD

  24 Months

• TBS

  24 Months

Other Outcomes (2)

• CTX

  12 Months

• P1NP

  12 Months

Study Arms (4)

Women Denosumab

EXPERIMENTAL

Semi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).

Drug: denosumab; Dietary Supplement: Calcium and Vitamin D

Women Placebo Group

PLACEBO COMPARATOR

Semi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).

Drug: Placebo; Dietary Supplement: Calcium and Vitamin D

Men Denosumab

EXPERIMENTAL

Semi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).

Drug: denosumab; Dietary Supplement: Calcium and Vitamin D

Men Placebo Group

PLACEBO COMPARATOR

Semi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements)

Drug: Placebo; Dietary Supplement: Calcium and Vitamin D

Interventions

denosumab DRUG

Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Also known as: Prolia

Men Denosumab; Women Denosumab

Placebo DRUG

Semi-annual saline injection

Men Placebo Group; Women Placebo Group

Calcium and Vitamin D DIETARY_SUPPLEMENT

Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Men Denosumab; Men Placebo Group; Women Denosumab; Women Placebo Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Institutionalized residents with subacute illnesses who are not expected to survive or who will be discharged in \< 2 years.
• Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table).
• Those currently on therapy (including bisphosphonate, denosumab, or teriparatide) or who have been on a bisphosphonate for \> 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.

Sponsors & Collaborators

• Susan L. Greenspan: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UPMC Senior Communities

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis; Osteoporotic Fractures; Bone Diseases, Metabolic

Interventions

Denosumab; Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Susan Greenspan
• Organization: University of Pittsburgh

greenspn@pitt.edu

+14126922477

Study Officials

• Susan L Greenspan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)