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Monoclonal Antibodies

Romosozumab + Teriparatide for Osteoporosis (CAT Trial)

Phase 4
Waitlist Available
Led By Benjamin Leder, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women aged 45+
Postmenopausal
Must not have
No significant previous use of bone health modifying treatments
Known congenital or acquired bone disease other than osteoporosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 0 to 12
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial is looking at how two different FDA-approved medications work in treating osteoporosis in women after menopause."

Who is the study for?
This trial is for postmenopausal women aged 45 and older who have osteoporosis with a high risk of fractures. Participants should not have used bone health treatments significantly before, nor should they have other bone diseases, serious kidney or liver issues, heart/lung problems, psychiatric disorders, abnormal calcium levels, severe vitamin D deficiency, anemia or a history of cancer (except skin cancer). They also shouldn't abuse alcohol or substances.
What is being tested?
The study is examining the effects of two FDA-approved medications for treating postmenopausal osteoporosis: Romosozumab and Teriparatide. It aims to understand how these drugs work in managing the condition and preventing fractures.
What are the potential side effects?
Possible side effects from Romosozumab may include joint pain, headache, injection site reactions like redness and swelling; while Teriparatide can cause nausea, dizziness upon standing up too fast due to low blood pressure (orthostatic hypotension), leg cramps and increased chance of kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 45 or older.
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I have gone through menopause.
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I have osteoporosis with a high risk of breaking bones.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used significant bone health treatments.
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I have a bone condition that is not osteoporosis.
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I have had cancer before, but not skin cancer.
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I am allergic or react badly to romosozumab or teriparatide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 0 to 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 0 to 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lumbar spine areal bone mineral density

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: RomosozumabActive Control1 Intervention
romosozumab
Group II: Romosozumab and TeriparatideActive Control2 Interventions
romosozumab and teriparatide

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,006 Previous Clinical Trials
13,307,232 Total Patients Enrolled
22 Trials studying Osteoporosis
1,439 Patients Enrolled for Osteoporosis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
495 Previous Clinical Trials
1,089,442 Total Patients Enrolled
39 Trials studying Osteoporosis
67,062 Patients Enrolled for Osteoporosis
Benjamin Leder, MDPrincipal InvestigatorMGH
4 Previous Clinical Trials
179 Total Patients Enrolled
4 Trials studying Osteoporosis
179 Patients Enrolled for Osteoporosis
~33 spots leftby Apr 2027
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