50 Participants Needed

Romosozumab + Teriparatide for Osteoporosis

(CAT Trial)

AP
Overseen ByAparna Patnaik, BA
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been using bone health treatments, you may not be eligible to participate.

What data supports the effectiveness of the drug combination Romosozumab and Teriparatide for osteoporosis?

Research shows that Romosozumab significantly improves bone density and structure compared to Teriparatide, with greater increases in bone thickness and density in women with low bone density. This suggests that Romosozumab is effective in promoting bone formation and reducing bone loss.12345

Is the combination of Romosozumab and Teriparatide safe for treating osteoporosis?

Romosozumab and Teriparatide have been studied for osteoporosis, showing they can help with bone health. However, there are concerns about potential cardiovascular risks (heart-related issues) with Romosozumab, so it's important to discuss these with a doctor.12346

How is the drug combination of Romosozumab and Teriparatide for osteoporosis different from other treatments?

Romosozumab and Teriparatide work together to both build new bone and increase bone density, which is different from many other osteoporosis treatments that primarily focus on slowing bone loss. This combination offers a dual approach by stimulating bone formation and reducing the risk of fractures.7891011

Research Team

BL

Benjamin Leder, MD

Principal Investigator

MGH

Eligibility Criteria

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.

Inclusion Criteria

I am a woman aged 45 or older.
I have gone through menopause.
I have osteoporosis with a high risk of breaking bones.

Exclusion Criteria

I am allergic or react badly to romosozumab or teriparatide.
I haven't used significant bone health treatments.
I do not have severe kidney, liver, heart/lung, or mental health conditions.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either romosozumab or a combination of romosozumab and teriparatide for the treatment of postmenopausal osteoporosis

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Romosozumab
  • Teriparatide
Trial Overview 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.
Participant Groups
2Treatment groups
Active Control
Group I: RomosozumabActive Control1 Intervention
romosozumab
Group II: Romosozumab and TeriparatideActive Control2 Interventions
romosozumab and teriparatide

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

Findings from Research

Romosozumab significantly improved bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck compared to teriparatide, with notable improvements observed at both 6 and 12 months in a review of 4 studies involving 1304 patients.
Romosozumab had fewer injection-site reactions compared to teriparatide, and there were no significant differences in serious adverse events or mortality, indicating a favorable safety profile.
Romosozumab versus Teriparatide for the Treatment of Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis through a Grade Analysis of Evidence.Tian, A., Jia, H., Zhu, S., et al.[2023]
Romosozumab significantly reduces the incidence of new vertebral fractures in postmenopausal women with osteoporosis after just 12 months of treatment, showing strong efficacy compared to both placebo and active bisphosphonate controls.
However, there is a concerning numerical increase in cardiovascular events associated with romosozumab, suggesting it should be used cautiously, especially in patients with a history of cardiovascular issues or high cardiovascular risk.
Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk.Fixen, C., Tunoa, J.[2021]
In a Phase II study involving 123 patients with relapsing forms of multiple sclerosis (MS), teriflunomide was found to be well tolerated as an add-on therapy to glatiramer acetate, with low rates of adverse events leading to treatment discontinuation.
Teriflunomide significantly reduced MRI markers of disease activity, showing a 64% relative reduction in T1-Gd lesions at the 7 mg dose compared to placebo, indicating its potential efficacy in managing MS.
A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis.Freedman, MS., Wolinsky, JS., Truffinet, P., et al.[2020]

References

Romosozumab versus Teriparatide for the Treatment of Postmenopausal Osteoporosis: A Systematic Review and Meta-analysis through a Grade Analysis of Evidence. [2023]
Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. [2018]
[Control of bone remodeling by bone anabolic drugs.] [2018]
Efficacy of Three Teriparatide Preparations and Romosozumab, Osteogenesis Promoters, in the Treatment of Fresh Vertebral Fractures: A Retrospective Observational Study. [2023]
Romosozumab Enhances Vertebral Bone Structure in Women With Low Bone Density. [2022]
Romosozumab: a Review of Efficacy, Safety, and Cardiovascular Risk. [2021]
Teriflunomide for the treatment of relapsing multiple sclerosis: a review of clinical data. [2021]
A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. [2020]
Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. [2022]
The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. [2021]
Teriflunomide attenuates immunopathological changes in the dark agouti rat model of experimental autoimmune encephalomyelitis. [2022]
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