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Purpose

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

Condition

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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/mL or >60ng/mL - serum alkaline phosphatase above upper normal limit with no explanation - anemia (hematocrit <32%) - history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis - history of urolithiasis within the last one year - excessive alcohol use or substance abuse - use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months - extensive dental work involving extraction or dental implant within the past or upcoming 2 months - known sensitivity to mammalian cell-derived drug products - known contraindications to denosumab, teriparatide, or any of their excipients - known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class - continuous use of tetracycline for >1-month duration within the last 10 years

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Teriparatide only 		daily subcutaneous injection teriparatide for 3 months
  • Drug: Teriparatide
    teriparatide daily subcutaneous injection
    Other names:
    • Forteo
Active Comparator
Denosumab only 		one dose of subcutaneous injection denosumab
  • Drug: Denosumab
    denosumab subcutaneous injection
    Other names:
    • Prolia
Active Comparator
Denosumab and teriparatide 		daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
  • Drug: Teriparatide
    teriparatide daily subcutaneous injection
    Other names:
    • Forteo
  • Drug: Denosumab
    denosumab subcutaneous injection
    Other names:
    • Prolia

More Details

Status
Completed
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.