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Completed

NCT Number: NCT04026256

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

teriparatide daily subcutaneous injection

Other names: Forteo

Denosumab

Drug

denosumab subcutaneous injection

Other names: Prolia

Primary outcomes

  1. Cancellous Bone Formation Rate at Month 3

    Time frame: 3 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.

    Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated.

    Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling.

    Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2019
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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