Romosozumab for Osteoporosis

Overseen By Rohit Prem Kumar, M.D.

Age: 65+

Sex: Female

Trial Phase: Phase 2

Sponsor: Nitin Agarwal

Must not be taking: Osteoporosis medications, Anabolic agents

Disqualifiers: Male, Severe renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 12 months

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery

Research Team

Nitin Agarwal, M.D.

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for postmenopausal women with osteoporosis who are planning to have lumbar spine surgery. They should be willing to receive monthly injections or take weekly pills, and attend five study visits over a year. Details about specific inclusion and exclusion criteria were not provided.

Inclusion Criteria

Able to provide informed consent

I am a woman who has gone through menopause.

I have been diagnosed with osteoporosis.

Exclusion Criteria

I am male.

My surgery will fuse more than 4 spine levels.

Uncorrected hypocalcemia and/or hypovitaminosis D

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either romosozumab or alendronate. Romosozumab is administered as monthly injections, while alendronate is taken weekly. Surgery is performed 3 months after treatment initiation.

12 months

5 visits (in-person)

Surgery

Participants undergo lumbar spine surgery 3 months after starting treatment.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months and 9 months post-operation.

9 months

Treatment Details

Interventions

• Romosozumab

Trial Overview The trial tests if romosozumab (monthly injection) improves bone density and muscle mass better than alendronate (weekly pill) in the context of spine surgery recovery. Participants will also get vitamin supplements and a dose of zoledronic acid, with health assessments before and after surgery.

Participant Groups

Group I: Romosozumab + Placebo Alendronate Experimental Treatment 2 Interventions

Participants will receive monthly subcutaneous injections of romosozumab (210 mg, one injection per arm) for 12 months, along with weekly oral placebo alendronate. Surgery will be performed 3 months after treatment initiation. DXA and CT scans will assess bone density and muscle mass. Functional outcomes will be evaluated via PROMs at baseline and follow-up.

Group II: Alendronate + Placebo Romosozumab Active Control 2 Interventions

Participants will receive weekly oral doses of alendronate (70 mg) and monthly subcutaneous placebo injections mimicking romosozumab. Surgery will occur after 3 months of treatment. Bone density, muscle mass, and functional outcomes will be assessed similarly to the experimental arm.

Who Is Running the Clinical Trial?

Nitin Agarwal

Lead Sponsor

Trials

2

Recruited

200+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Beckwith Foundation

Collaborator

Trials

2

Recruited

210+