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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

NCTNCT04026256 (opens ClinicalTrials.gov in a new tab)Other id2018P002537Other id5R01AR073191-04
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
37 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
2 Sept 2019
Primary completion
18 Apr 2022
Completion
18 Apr 2022
First posted
19 Jul 2019
Last update posted
2 Aug 2023
Conditions
Postmenopausal Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph 4

    Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

    NCT04026256

    2 Sept 2019 to 18 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • DenosumabDrug

Arms3

  • Active comparator

    Teriparatide only

    daily subcutaneous injection teriparatide for 3 months

  • Active comparator

    Denosumab only

    one dose of subcutaneous injection denosumab

  • Active comparator

    Denosumab and teriparatide

    daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Cancellous Bone Formation Rate at Month 3

    Time frame · 3 months after first dose of study drug

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months after first dose of study drug

Cancellous Bone Formation Rate at Month 3

GroupValue (mm3/mm2/day)Spread
Teriparatide Only0.130.06
Denosumab Only0.010.01
Denosumab and Teriparatide0.060.02

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide Onlydaily subcutaneous injection teriparatide for 3 months Teriparatide: teriparatide daily subcutaneous injection0 / 131 / 135 / 13
Denosumab Onlyone dose of subcutaneous injection denosumab Denosumab: denosumab subcutaneous injection0 / 90 / 96 / 9
Denosumab and Teriparatidedaily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab Teriparatide: teriparatide daily subcutaneous injection Denosumab: denosumab subcutaneous injection0 / 121 / 129 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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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