Osteoclast Inhibition and Bone Formation

Aging Clinical Trial

Official title:

Effects of Age and Osteoclast Inhibition on Bone Formation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554695
• Other study ID #: 15-002313
• Status: Completed
• Phase: Early Phase 1
• First received: September 17, 2015
• Last updated: January 3, 2018
• Start date: October 20, 2015
• Est. completion date: October 25, 2016

Study information

• Verified date: January 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Aging
• Bone Loss

Intervention

Drug:
• placebo
subcutaneous saline injection
• denosumab
single subcutaneous injection of denosumab 60 mg

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression changes in bone cells	Ratio of selected genes as expressed between each of the 3 arms (i.e. relative runx2 gene expression levels in each arm).	3 months
Secondary	Osteoclast-osteoblast coupling factor changes	Ratio of selected genes as expressed between each of the 3 arms (i.e. relative runx2 gene expression levels in each arm).	3 months