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Combined Anabolic Therapy (CAT)

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Mass General Brigham

Status and phase

Begins enrollment in 2 months
Phase 4

Conditions

Osteoporosis
Osteoporosis, Postmenopausal

Treatments

Drug: Romosozumab
Drug: Teriparatide

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06558188
2024P002279
1R21AR083567-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Female

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture

Exclusion criteria

  • no significant previous use of bone health modifying treatments
  • known congenital or acquired bone disease other than osteoporosis
  • significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
  • abnormal calcium or parathyroid hormone level
  • serum vitamin D <20 ng/dL
  • anemia (hematocrit <32%)
  • history of malignancy (except non-melanoma skin carcinoma)
  • excessive alcohol use or substance abuse
  • known contraindications to romosozumab or teriparatide

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Romosozumab
Active Comparator group
Description:
romosozumab
Treatment:
Drug: Romosozumab
Romosozumab and Teriparatide
Active Comparator group
Description:
romosozumab and teriparatide
Treatment:
Drug: Teriparatide
Drug: Romosozumab

Trial contacts and locations

1

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Central trial contact

Aparna Patnaik, BA

Data sourced from clinicaltrials.gov

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