AzTrials
AzTrials

OsteoporosisPhase 2NCT04708886

Romosozumab in Women With Chronic SCI

A Phase 2 study testing Romosozumab and Alendronate in people with Osteoporosis and Bone Loss, run by Northwestern University 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
Search all trials

Trial summary

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Osteoporosis, Bone Loss, Osteopenia, Osteoporosis
What is being tested?
Romosozumab and Alendronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Mar 2021to 10 Jun 2024
Phase
Phase 2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Female sex
  • SCI 6 or more months prior to enrollment
  • Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)
  • Osteoporosis by DXA defined as a t-score of -2.5 at any skeletal site (lumbar spine, total hip, or femoral neck) or a t-score of -2.0 plus a history of a fragility fracture
  • Good general health, as determined by the study investigator
Show all 14Show fewer
  • Able to understand and agree to informed consent in English
  • Able and willing to complete all the study visits
  • Females of childbearing potential must be willing and able to use an effective method of contraception or practice abstinence throughout the course of the study and up to 90 days after the last use of study drug.
  • Vitamin D 25-hydroxy levels ≥ 20 ng/ml (subjects may be repleted and retested prior to baseline)
  • Normal serum calcium levels (based on current local laboratory normal range)
  • No known endocrinopathies (diabetes type 1 or 2, treated thyroid conditions can be included)
  • Normal serum thyroid stimulating hormone and/or T4 levels (based on current local laboratory normal ranges)
  • Able to take oral medication sitting upright for at least 30 minutes

Who cannot join

  • Have Paget's disease of the bone
  • Have abnormal laboratory values that in the judgement of the investigator would put the participant at increased risk of treatment
  • Any active gastrointestinal condition that results in malabsorption
  • Abnormalities of the esophagus which delay emptying such as stricture or achalasia
  • Known hypersensitivity to romosozumab or alendronate
  • Increased risk of aspiration
Show all 18Show fewer
  • Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, or planned invasive dental procedure over the next two years
  • Heterotopic ossification of the knee region that interferes with CT analysis
  • History of bone metastasis and skeletal malignancies
  • History of alcoholism or drug abuse within the 2 years prior to study screening, which in the opinion of the investigator may affect subject's health and/or study commitment
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study
  • Currently being prescribed anticonvulsants at a dose or frequency that is determined to interfere with bone metabolism as determined by the investigator
  • Currently being prescribed glucocorticoids, other than inhaled glucocorticoids
  • Current or use during past 5 years of any bone-active agents, including any FDA approved treatment (e.g., teriparatide, abaloparatide, denosumab, any bisphosphonate (oral or IV), raloxifene, bazedoxifene, hormone therapy (estrogen and estrogen/progestin) and calcitonin) as well as any strontium-containing compounds.
  • Pregnant, planning to become pregnant, or lactating
  • Any history of stroke or cardiovascular disease other than controlled hypertension
  • Renal insufficiency (calculated creatinine clearance less than 35 ml/min)
  • Any other neurological impairment that may impair ambulation or muscle function

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis

This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.

Read the detailed description

This is a single-site, singe-arm, open-label pilot study to evaluate safety and efficacy of a sequential drug treatment (12 months of romosozumab injections followed by 12 months with alendronate tablets) to treat bone loss in women with chronic SCI and OP.

During the first year, participants will receive monthly subcutaneous injections of romosozumab 210 mg. This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments. During the second year, participants will take weekly oral alendronate 70 mg. Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP. In this study, it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab.

Twelve participants will receive the study drug treatment, take daily supplements (calcium and vitamin D), and return to the research site for study visits over the course of two years. Computerized tomography (CT) imaging, dual-energy X-ray absorptiometry (DXA) imaging, and serum bone markers will be collected at various time points.

Being tested
Romosozumab, Alendronate
Keywords
Spinal Cord Injury, Osteoporosis, Romosozumab (Evenity), Alendronate (Fosamax), Bone Diseases, Metabolic Bone Diseases, Anabolic Treatment, Bisphosphonate, Bone Density, Spinal Cord Diseases, Romosozumab, Alendronate, Physiological Effects of Drugs
Medical subject headings
Osteoporosis, Bone Diseases, Metabolic, Spinal Cord Injuries, Bone Diseases, Spinal Cord Diseases

What participants receive

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

  • RomosozumabDrug

    Also called Evenity

    Year 1 study drug

  • AlendronateDrug

    Also called Fosamax

    Year 2 study drug

Study groups in NCT04708886
Study groupRoleWhat they receive
Females with Chronic SCIExperimental12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)
Receives: Drug: Romosozumab; Drug: Alendronate

What is being measured

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

  1. Change in Integral vBMC at the Knee (Distal Femur)

    Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.

    Measured: Baseline - 12 months

Secondary outcomes (3)

  1. Change in BMD at the Total Hip and Femoral Neck

    Change from baseline to the Month 12 visit in bone mineral density (BMD) obtained via DXA (two-dimensional) imaging of the total hip.

    Measured: Baseline - 12 months

  2. Change in vBMC at the Hip

    Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT imaging of the hip.

    Measured: Baseline - 12 months

  3. Change in Serum Bone Biomarkers (CTX and P1NP)

    Change from baseline to the Month 12 visit in serum levels of CTX and P1NP.

    Measured: Baseline - 12 months

Timeline

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

  1. First posted14 Jan 2021
  2. Study start1 Mar 2021
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708886
Sponsor's protocol ID
STU00212405
Other IDs
20197268
Status last verified
Sep 2025
First submitted
12 Jan 2021
Last updated
24 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, Hofbauer LC, Lau E, Lewiecki EM, Miyauchi A, Zerbini CA, Milmont CE, Chen L, Maddox J, Meisner PD, Libanati C, Grauer A. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 Oct 20;375(16):1532-1543. doi: 10.1056/NEJMoa1607948. Epub 2016 Sep 18.

    PubMed 27641143

  • Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

    PubMed 28892457

  • Keaveny TM, Crittenden DB, Bolognese MA, Genant HK, Engelke K, Oliveri B, Brown JP, Langdahl BL, Yan C, Grauer A, Libanati C. Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017 Sep;32(9):1956-1962. doi: 10.1002/jbmr.3176. Epub 2017 Jun 26.

    PubMed 28543940

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Romosozumab and Alendronate in people with Osteoporosis and Bone Loss, run by Northwestern University 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 14 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: finished, as of the sponsor's last update on 24 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 Sep 2025). 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?

Change in Integral vBMC at the Knee (Distal Femur) (time frame: Baseline - 12 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 NCT04708886, 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 24 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in