Osteoclast Inhibition and Bone Formation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-20

Study Completion Date

2016-10-25

Brief Summary

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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?

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Detailed Description

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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?

Conditions

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Bone Loss Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

single subcutaneous injection of placebo (normal saline)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous saline injection

Denosumab

single subcutaneous injection of denosumab 60 mg

Group Type ACTIVE_COMPARATOR

denosumab

Intervention Type DRUG

single subcutaneous injection of denosumab 60 mg

young normal premenopausal women

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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placebo

subcutaneous saline injection

Intervention Type DRUG

denosumab

single subcutaneous injection of denosumab 60 mg

Intervention Type DRUG

Other Intervention Names

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saline Prolia

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes