Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

  • STATUS
    Recruiting
  • End date
    Jun 1, 2022
  • participants needed
    36
  • sponsor
    Massachusetts General Hospital
Updated on 11 April 2021
denosumab
crest
teriparatide

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.

Details
Condition Osteoporosis, Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment Denosumab, Teriparatide
Clinical Study IdentifierNCT04026256
SponsorMassachusetts General Hospital
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

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
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