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Recruiting NCT06558188

Combined Anabolic Therapy

Phase IV Interventional Osteoporosis, Postmenopausal Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Romosozumab, Teriparatide.
Who it may be relevant to
Registry conditions: Osteoporosis, Postmenopausal, Osteoporosis. Basic parameters: from 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Combined Anabolic Therapy Study

Overview

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.

Interventions

  • Drug Romosozumab
    romosozumab 210 milligrams monthly
  • Drug Teriparatide
    teriparatide 20 micrograms daily

Primary outcome measures

  • Lumbar spine areal bone mineral density [Time frame: Month 0 to 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT06558188 · 2024P002279 · 1R21AR083567-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗