Osteoporosis, PostmenopausalPhase 4PROUDNCT02753283

Preventing Osteoporosis Using Denosumab

A Phase 4 study testing denosumab and Calcium and Vitamin D in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Susan L. Greenspan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
What is being tested?: denosumab and Calcium and Vitamin D
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 201 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Aug 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Senior Communities
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Sustaining Skeletal Health in Frail Elderly

Read the detailed description

Objective:

The long term goal is to improve health, well-being and quality of life in the frail long-term care (LTC) elderly population by reducing fractures. The short term goal is to demonstrate efficacy of the non-bisphosphonate denosumab to improve bone mineral density (BMD), a necessary (but not sufficient) pre-condition of a large fracture reduction trial. The investigators propose to conduct a 2-year, randomized, double-blind, calcium-vitamin D controlled trial to test the efficacy and predictability of the antiresorptive RANK ligand inhibitor, denosumab (60 mg), among a cohort of 212 institutionalized, under-served, frail men and women ≥65 years old in LTC.

Specific Aims:

Aim 1: To evaluate efficacy of denosumab in improving/maintaining bone mineral density. The investigators will measure conventional hip and spine bone mineral density (BMD).

Primary Hypothesis: After 2 years, women and men on denosumab will have greater hip and spine BMD increases.

Conditions: Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
Being tested: denosumab, Placebo, Calcium and Vitamin D
Keywords: Bone loss, Frail Geriatric Patients, Nursing Home Patients, Long-term Care Patients, Osteoporosis, Osteoporotic Fractures
Medical subject headings: Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

denosumabDrug
Also called Prolia
Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
PlaceboDrug
Semi-annual saline injection
Calcium and Vitamin DDietary supplement
Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)

Study groups in NCT02753283
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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) Receives: Drug: Placebo; Dietary Supplement: Calcium and Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 24 months

Secondary outcomes (3)

Distal Radius BMD
Percent change over 24 months
Measured: 24 Months
Femoral Neck BMD
Percent change over 24 months
Measured: 24 Months
TBS
Trabecular Bone Score (TBS) Percent change over 24 months. This not a scale. Higher values are better.
Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Aug 2023

First posted27 Apr 2016 (estimated)
Study startJun 2016
Primary completionAug 2023
Study completionAug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753283
Sponsor's protocol ID: STUDY19050268
Other IDs: 1R01AG052123-01
Acronym: PROUD
Status last verified: Aug 2024
First submitted: 25 Apr 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
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Recruiting
Study of the Impact of Mother-of-pearl Nutritional Supplementation on the Prevention of Post-menopausal Osteoporosis
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Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
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All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sustaining Skeletal Health in Frail Elderly
ClinicalTrials.gov ID: NCT02753283
Acronym / sponsor ID: PROUD / STUDY19050268
Conditions: Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures
Keywords: Bone loss, Frail Geriatric Patients, Nursing Home Patients, Long-term Care Patients, Osteoporosis, Osteoporotic Fractures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Susan L. GreenspanUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Aging (NIA)
Study start: Jun 2016 (actual)
Primary completion: Aug 2023 (actual)
Study completion: Aug 2023 (actual)
First posted: 27 Apr 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective:

Specific Aims:

Aim 1: To evaluate efficacy of denosumab in improving/maintaining bone mineral density. The investigators will measure conventional hip and spine bone mineral density (BMD).

Primary Hypothesis: After 2 years, women and men on denosumab will have greater hip and spine BMD increases.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Women Denosumab	Experimental	Drug: denosumab, Dietary Supplement: Calcium and Vitamin DSemi-annual dose for women: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
Women Placebo Group	Placebo comparator	Drug: Placebo, Dietary Supplement: Calcium and Vitamin DSemi-annual for women: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements).
Men Denosumab	Experimental	Drug: denosumab, Dietary Supplement: Calcium and Vitamin DSemi-annual dose for men: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplements).
Men Placebo Group	Placebo comparator	Drug: Placebo, Dietary Supplement: Calcium and Vitamin DSemi-annual for men: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium approximately1200 mg/daily (dietary + supplements)

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
denosumabAlso: ProliaSemi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)	Drug	Men Denosumab, Women Denosumab
PlaceboSemi-annual saline injection	Drug	Men Placebo Group, Women Placebo Group
Calcium and Vitamin DDietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)	Dietary supplement	Men Denosumab, Men Placebo Group, Women Denosumab, Women Placebo Group

Primary outcome

Bone Density of the Total Hip
Time frame: 24 months
Bone Mineral Density (BMD) of the total hip percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)
Bone Density of the Spine
Time frame: 24 months
Bone Mineral Density (BMD) of the spine percent change over 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

3 secondary outcomes

Distal Radius BMD
Time frame: 24 Months
Femoral Neck BMD
Time frame: 24 Months
TBS
Time frame: 24 Months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Women Denosumab	62	45
Women Placebo Group	61	43
Men Denosumab	40	28
Men Placebo Group	38	27

Primary outcome: Bone Density of the Total Hip

Time frame: 24 months. Mean (Standard Error). Unit: Percent change

Measure	Women Denosumab n = 40	Women Placebo Group n = 38	Men Denosumab n = 24	Men Placebo Group n = 24
Value	4.62 (0.62)	-0.19 (0.79)	3.74 (0.55)	0.48 (0.74)

Women Denosumab vs Women Placebo Group: Mean Difference (Final Values): 4.80, p = .007, Mixed Models Analysis
Men Denosumab vs Men Placebo Group: Mean Difference (Final Values): 2.70, p = .018, Mixed Models Analysis

Primary outcome: Bone Density of the Spine

Time frame: 24 months. Mean (Standard Error). Unit: Percent change

Measure	Women Denosumab n = 42	Women Placebo Group n = 41	Men Denosumab n = 26	Men Placebo Group n = 25
Value	7.41 (0.93)	2.15 (0.56)	7.91 (0.96)	1.12 (1.13)

Women Denosumab vs Women Placebo Group: Mean Difference (Final Values): 3.99, p = .014, Mixed Models Analysis
Men Denosumab vs Men Placebo Group: Mean Difference (Final Values): 5.16, p = .002, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women Denosumab	21 of 62 (33.9%)	46 of 62 (74.2%)	1 of 62
Women Placebo Group	26 of 61 (42.6%)	50 of 61 (82%)	4 of 61
Men Denosumab	21 of 40 (52.5%)	32 of 40 (80%)	4 of 40
Men Placebo Group	15 of 38 (39.5%)	33 of 38 (86.8%)	2 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan L Greenspan, MD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing denosumab and Calcium and Vitamin D in people with Osteoporosis, Postmenopausal and Osteoporosis, run by Susan L. Greenspan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Density of the Total Hip (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02753283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.