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Combined Anabolic Therapy (CAT)

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Mass General Brigham

Status and phase

Begins enrollment in 6 months
Phase 4

Conditions

Osteoporosis
Osteoporosis, Postmenopausal

Treatments

Drug: Romosozumab
Drug: Teriparatide

Study type

Interventional

Funder types

Other

Identifiers

NCT06558188
To be determined

Details and patient eligibility

About

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

Enrollment

46 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

46 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

0

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Central trial contact

Aparna Patnaik, BA

Data sourced from clinicaltrials.gov

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