Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2022-04-18

Brief Summary

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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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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Teriparatide only

daily subcutaneous injection teriparatide for 3 months

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

teriparatide daily subcutaneous injection

Denosumab only

one dose of subcutaneous injection denosumab

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type DRUG

denosumab subcutaneous injection

Denosumab and teriparatide

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

Group Type ACTIVE_COMPARATOR

Teriparatide

Intervention Type DRUG

teriparatide daily subcutaneous injection

Denosumab

Intervention Type DRUG

denosumab subcutaneous injection

Interventions

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Teriparatide

teriparatide daily subcutaneous injection

Intervention Type DRUG

Denosumab

denosumab subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Forteo Prolia

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes