What side effects are associated with this type of intervention?

Romosozumab, used to treat bone loss, can cause joint pain, headache, and may increase the risk of cardiovascular events. Alendronate, another common treatment, can lead to gastrointestinal issues such as esophageal irritation, musculoskeletal pain, and in rare cases, osteonecrosis of the jaw and atypical femoral fractures. Both drugs are effective in improving bone density but have distinct side effect profiles.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Spinal Cord Injury (SCI) that directly align with the mechanisms of Romosozumab or Alendronate. However, both drugs are approved for the treatment of osteoporosis. Romosozumab, a sclerostin inhibitor, is approved for increasing bone formation and decreasing bone resorption in postmenopausal women with osteoporosis at high risk for fracture. Alendronate, a bisphosphonate, is approved for the treatment and prevention of osteoporosis by inhibiting osteoclast-mediated bone resorption. While these drugs are not specifically approved for SCI, their roles in bone health and fracture prevention may offer insights into potential therapeutic strategies for SCI-related bone loss.

What other types of research exist?

Promising novel alternatives to Romosozumab and Alendronate for SCI patients in 2024 include Denosumab (a RANKL inhibitor that prevents osteoclast formation, leading to decreased bone resorption) and Abaloparatide (a parathyroid hormone-related protein analog that stimulates bone formation). Both have shown efficacy in increasing bone mineral density and reducing fracture risk in osteoporosis patients.

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Monoclonal Antibodies

Romosozumab for Osteoporosis in Women with Spinal Cord Injury

Phase 2

Waitlist Available

Led By Thomas J Schnitzer, MD, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)

Able and willing to complete all the study visits

Must not have

Any history of stroke or cardiovascular disease other than controlled hypertension

Heterotopic ossification of the knee region that interferes with CT analysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment for women with spinal injuries and weak bones. It starts with regular injections to build bone, followed by frequent pills to keep the bones strong.

Who is the study for?

This trial is for women over 18 with chronic spinal cord injury and osteoporosis, who've been non-ambulatory for at least 6 months. They must be in good health, have normal vitamin D and thyroid levels, not be pregnant or breastfeeding, able to take oral meds properly, and willing to use contraception if of childbearing potential.

What is being tested?

The study tests romosozumab's effectiveness on bone loss in the first year through monthly injections followed by a second year taking alendronate tablets weekly. It aims to see how well these treatments improve bone density in women with SCI-related osteoporosis.

What are the potential side effects?

Potential side effects include joint pain, headache, injection site reactions (like redness or swelling), possible increased risk of heart attack or stroke with romosozumab. Alendronate may cause digestive issues like heartburn or ulcers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot walk or have severe difficulty walking.

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I can attend all required study visits.

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I am female.

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I have osteoporosis, confirmed by a DXA scan.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of stroke or heart disease, but not high blood pressure.

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I have bone growth in my knee that affects CT scans.

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I am taking medication for seizures that may affect my bone health.

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I am currently taking glucocorticoid medication, not including inhalers.

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I haven't used any bone-strengthening drugs in the last 5 years.

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I am allergic to romosozumab or alendronate.

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I have a neurological condition that affects my ability to walk or move my muscles.

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My kidneys are not working well (low creatinine clearance).

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I am at a higher risk of choking on food or liquids.

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I have Paget's disease of the bone.

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I have a condition that slows down my esophagus from emptying.

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I have had cancer spread to my bones.

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I have a digestive condition that affects how my body absorbs nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in knee integral vBMC

Secondary study objectives

Change in hip BMD

Change in hip vBMC

Other study objectives

Change in BMC and BMD at regions of interest around the knee

Change in serum bone markers

Side effects data

From 2016 Phase 3 trial • 245 Patients • NCT02186171

21%

Nasopharyngitis

Back pain

Hypertension

Constipation

Arthralgia

Headache

Procedural pain

Muscle spasms

Myalgia

Depression

Appendicitis perforated

Pneumonia

Implant site haematoma

Thoracic vertebral fracture

Death

Cerebral ischaemia

Depressed mood

Atrial flutter

Appendicitis

Osteoarthritis

Vascular encephalopathy

Urinary tract infection

Carotid artery stenosis

Anaemia postoperative

Haemorrhagic stroke

Cholecystitis

Non-cardiac chest pain

Benign prostatic hyperplasia

Angina unstable

Cardio-respiratory arrest

Basal cell carcinoma

Coronary artery stenosis

Wolff-Parkinson-White syndrome

Cerebrovascular accident

Escherichia sepsis

Subdural haematoma

Oropharyngeal cancer

Device related infection

Myocardial ischaemia

Gastrooesophageal reflux disease

Carotid arteriosclerosis

Cardiac failure

Laceration

Rib fracture

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Romosozumab 210 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Females with Chronic SCIExperimental Treatment2 Interventions

12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alendronate

2012

Completed Phase 4

~6930

Romosozumab

2021

Completed Phase 4

~13930

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Romosozumab and alendronate are common treatments for managing bone health in Spinal Cord Injury (SCI) patients. Romosozumab works by inhibiting sclerostin, a protein that reduces bone formation, thereby increasing bone formation and decreasing bone resorption. This is vital for SCI patients who are prone to severe osteoporosis and fractures. Alendronate, a bisphosphonate, inhibits osteoclast-mediated bone resorption, preventing bone loss. Together, these treatments help maintain bone density and reduce fracture risk, addressing the critical need for effective bone health management in SCI patients.

Advances and Unmet Needs in the Therapeutics of Bone Fragility.Osteoanabolic and dual action drugs.