Current partner codePEPTIDESDE
NCT04026256·Phase 4·INTERVENTIONAL

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Status

Completed

Phase

Phase 4

Enrollment

37

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Teriparatide

teriparatide daily subcutaneous injection

DRUG

Denosumab

denosumab subcutaneous injection

Timeline

From registration to results.

  1. First posted

    Jul 19, 2019

  2. Study start

    Sep 2, 2019

  3. Primary completion

    Apr 18, 2022

  4. Study completion

    Apr 18, 2022

  5. Results posted

    Aug 2, 2023

  6. Registry updated

    Aug 2, 2023

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
45 Years
Maximum age
Not reported
Sex
FEMALE
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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Massachusetts General Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.