Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Registration Number
NCT04026256
Lead Sponsor
Massachusetts General Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
37
Inclusion Criteria
  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Denosumab and teriparatideDenosumabdaily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
Teriparatide onlyTeriparatidedaily subcutaneous injection teriparatide for 3 months
Denosumab onlyDenosumabone dose of subcutaneous injection denosumab
Denosumab and teriparatideTeriparatidedaily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
Primary Outcome Measures
NameTimeMethod
Cancellous Bone Formation Rate at Month 33 months after first dose of study drug

Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens.
...

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

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