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NCT Number: NCT02049866

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

The purpose of this research study is to evaluate antiresorptive therapy with denosumab (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal women with idiopathic osteoporosis.

Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial, "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6 months).

The goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. This study presents the first opportunity to study the effects of denosumab after TPTD in this unique and severely affected group of young women.

Funding Source: FDA Office of Orphan Products Development (OOPD).

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Key information

Conditions

Adult Idiopathic Generalized Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Creighton University, Omaha, Nebraska, United States

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About this study

Osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (IOP). IOP is a rare disease with an estimated prevalence of <200,000 affected premenopausal women in the United States.

Denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (BMD). Moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. The investigators hypothesize that denosumab, initiated after completion of two years of TPTD, will maintain or improve central and peripheral areal and volumetric BMD, microstructure and stiffness in premenopausal women with IOP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women completing NCT01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study.
  • (Premenopausal status is no longer be required for entry.)

Exclusion criteria

  • Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine transaminase (ALT) above upper limit of normal
  • Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL
  • Pregnancy: urine pregnancy test must be negative

Treatment and study plan

Denosumab

Drug

Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months

Other names: Prolia, Xgeva

Primary outcomes

  1. Percent Change in Lumbar Spine Areal BMD by DXA

    Time frame: Baseline and 12 months

    Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Secondary outcomes

  1. Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months

    Time frame: Baseline and 24 months

    Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Sponsors and collaborators

Lead sponsor

Elizabeth Shane

Other

Collaborators

  • Creighton University

Registry information

Official study title

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With Idiopathic Osteoporosis (IOP)

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2014
Registry last updated
Dec 12, 2022

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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