This trial is active, not recruiting.

Conditions bone loss, aging
Treatments placebo, denosumab
Sponsor Mayo Clinic
Start date October 2015
End date December 2016
Trial size 75 participants
Trial identifier NCT02554695, 15-002313


This protocol addresses: 1) How gene expression changes in bone cells are affected by aging? 2) Is aging associated with decreased signaling between bone cells? 3) How does treatment with the osteoporosis medication denosumab affect bone cell signaling?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
(Placebo Comparator)
single subcutaneous injection of placebo (normal saline)
placebo saline
subcutaneous saline injection
(Active Comparator)
single subcutaneous injection of denosumab 60 mg
denosumab Prolia
single subcutaneous injection of denosumab 60 mg
(No Intervention)
no intervention

Primary Outcomes

Gene expression changes in bone cells
time frame: 3 months

Secondary Outcomes

Osteoclast-osteoblast coupling factor changes
time frame: 3 months

Eligibility Criteria

Female participants from 25 years up to 80 years old.

- Inclusion Criteria: - normal premenopausal women aged 25-40 years - normal postmenopausal women aged 60-80 years - at least 5 yrs since their last menses - follicle stimulating hormone (FSH) > 20 IU/L - Exclusion Criteria: - Abnormality in any of the screening laboratory studies - Presence of significant liver or renal disease - Malignancy (including myeloma) - Malabsorption - Diabetes - Hypoparathyroidism - Hyperparathyroidism - Acromegaly - Cushing's syndrome - Hypopituitarism - Severe chronic obstructive pulmonary disease - Undergoing treatment with any medications that affect bone turnover, including the following: - adrenocorticosteroids (> 3 months at any time or > 10 days within the previous yr) - anticonvulsant therapy (within the previous year) - pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal) - calcium supplementation of > 1200 mg/d (within the preceding 3 months) - bisphosphonates (within the past 3 yrs) - denosumab - estrogen (E) therapy within the past year - treatment with a selective E receptor modulator within the past year - teriparatide within the past yr - Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm) - Recent (within the past 6 months) fracture - Serum 25-hydroxyvitamin D levels of < 20 ng/ml

Additional Information

Official title Effects of Age and Osteoclast Inhibition on Bone Formation
Principal investigator Sundeep Khosla, MD
Description This protocol collectively addresses the following goals: 1) What are the changes in gene expression in osteoblasts and osteocytes that lead to impaired bone formation with aging; 2) Since recent work from the investigators' group has demonstrated that osteoclasts produce a number of growth factors and cytokines (coupling factors) that enhance osteoblast proliferation and/or differentiation, is aging associated with reduced osteoclast coupling factor production; and 3) If osteoclasts are markedly reduced using the FDA-approved medication for osteoporosis, denosumab, how does that effect the quantity of coupling factors in the bone microenvironment and the target genes of these coupling factors in osteoblasts?
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.