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OsteoporosisPhase 4NCT05101018

Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

A Phase 4 study testing Romosozumab and Denosumab in people with Osteoporosis and Spinal Cord Injuries, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Osteoporosis, Spinal Cord Injuries
What is being tested?
Romosozumab and Denosumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
1 Nov 2021to 1 Nov 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C);
  • Duration of SCI less than 6 months;
  • Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review;

Who cannot join

  • Active and/or history of coronary heart disease or stroke;
  • Bone cancer;
  • Long-bone fracture of the leg within the past year;
  • History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.);
  • Postmenopausal women;
  • Men with known low functioning tests before SCI;
Show all 18Show fewer
  • Drugs geared toward increasing BMD longer than a six month duration after SCI;
  • As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year
  • Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.;
  • Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure);
  • Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.;
  • History of chronic alcohol abuse;
  • Diagnosis of hypercalcemia (high levels of calcium in the blood);
  • Pregnancy;
  • As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D;
  • Current diagnosis of cancer or history of cancer;
  • As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and
  • Life expectancy less than 5 years.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey, 07052

Other trials in United States

About this study

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Read the detailed description

Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Romosozumab is a human monoclonal anti-sclerostin antibody bone anabolic agent that recently gained FDA approval to treat osteoporosis in postmenopausal women. This study will test the ability of romosozumab administered in FDA-approved therapeutic doses for 12 months to prevent loss of BMD to regions of interest of the lower extremities in persons with subacute SCI; attention will be focused to the knee region (distal femur), but the proximal tibia and hip regions will also be acquired and analyzed. The ability of denosumab to preserve the gains in BMD attained with romosozumab will be determined.The romosozumab + denosumab group will be compared to a group that receives 24 months of denosumab.

In persons with acute/subacute motor-compete SCI (<6 months since SCI), the primary objectives in the intervention group are to maintain baseline values of sublesional distal femur aBMD at 12 months after single drug therapy (12 months of romosozumab) and at 24 months after sequential dual drug therapy (12 months of romosozumab followed by 12 months of denosumab). This dual drug intervention group will be compared to a group that receives denosumab for 24 months; each active drug group will be compared to a historical control (placebo) group.

Being tested
Romosozumab, Denosumab
Keywords
Osteoporosis, Spinal Cord Injuries, Dual Energy X-ray Absorptiometry, Denosumab, Romosozumab
Medical subject headings
Osteoporosis, Spinal Cord Injuries

What participants receive

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

  • RomosozumabDrug

    Also called Evenity

    Romosozumab (Amgen Inc., Thousand Oaks, CA) 210mg SQ administered each month

  • DenosumabDrug

    Also called Prolia

    Denosumab (Amgen Inc., Thousand Oaks, CA) 60 mg SQ administered every six months

Study groups in NCT05101018
Study groupRoleWhat they receive
Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24ExperimentalOf the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive romosozumab (210mg SQ) once a month for 12 months. After 12 months the same twenty (20) individuals will receive denosumab (60mg SQ) at month 12 and 18.
Receives: Drug: Romosozumab; Drug: Denosumab
Denosumab Baseline to Month 24Active comparatorOf the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive denosumab (60 mg SQ) at baseline and 6, 12, and 18 months.
Receives: Drug: Denosumab

What is being measured

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

  1. Bone mineral density (BMD) of the distal femur metaphysis

    BMD at the distal femur metaphysis will be obtained by dual energy X-ray absorptiometry (DXA)

    Measured: Baseline to 24 months

Timeline

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

  1. First posted29 Oct 2021
  2. Study start1 Nov 2021
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Arm 1: romosozumab administered monthly from baseline to month 11 followed by denosumab at month 12 and 18. Arm 2: denosumab administered at baseline, month 6, 12, and 18
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101018
Sponsor's protocol ID
BAU-19-60
Status last verified
Sep 2025
First submitted
14 Oct 2021
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, Ebeling PR, Adachi JD, Miyauchi A, Gielen E, Milmont CE, Libanati C, Grauer A. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions: Results of the FRAME Extension Study. J Bone Miner Res. 2019 Mar;34(3):419-428. doi: 10.1002/jbmr.3622. Epub 2018 Dec 3.

    PubMed 30508316

  • Cosman F, Crittenden DB, Ferrari S, Khan A, Lane NE, Lippuner K, Matsumoto T, Milmont CE, Libanati C, Grauer A. FRAME Study: The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 Jul;33(7):1219-1226. doi: 10.1002/jbmr.3427. Epub 2018 May 17.

    PubMed 29573473

  • McClung MR, Brown JP, Diez-Perez A, Resch H, Caminis J, Meisner P, Bolognese MA, Goemaere S, Bone HG, Zanchetta JR, Maddox J, Bray S, Grauer A. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density: A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 Aug;33(8):1397-1406. doi: 10.1002/jbmr.3452. Epub 2018 May 22.

    PubMed 29694685

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Romosozumab and Denosumab in people with Osteoporosis and Spinal Cord Injuries, run by James J. Peters Veterans Affairs Medical Center at 2 sites 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 18 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

This study is still under way. Results are not available in the source record yet.

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 mineral density (BMD) of the distal femur metaphysis (time frame: Baseline to 24 months). 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 NCT05101018, which also lists 3 linked publications.

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 17 Sep 2025.

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