A Study of How Age Affects Osteoclast Inhibition and Bone Formation

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-002313
    NCT ID: NCT02554695
    Sponsor Protocol Number: 15-002313

About this study

This protocol addresses three main questions. How are gene expression changes in bone cells affected by aging?  Is aging associated with decreased signaling between bone cells? How does treatment with the osteoporosis medication denosumab affect bone cell signaling?

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Normal premenopausal women aged 25-40 years 
  • Normal postmenopausal women aged 60-80 years 
    • at least 5 years 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 year)
    • 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 years)
    • Denosumab 
    • Estrogen (E) therapy within the past year 
    • Treatment with a selective E receptor modulator within the past year
    • Teriparatide within the past year
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sundeep Khosla, M.D.

Closed for enrollment

Contact information:

Louise McCready R.N.

(507)284-4329

mccready.louise@mayo.edu