Osteoclast Inhibition and Bone Formation | NCT02554695

Studies
Osteoclast Inhibition and Bone Formation

NCT02554695

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jan 5, 2018Actual

Enrollment

81Actual

Phase

Early Phase 1

Conditions

Bone Loss
Aging

Interventions

placebo
denosumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2015Actual

Primary Completion Date

Oct 25, 2016Actual

Completion Date

Oct 25, 2016Actual

First Submitted Date

Sep 17, 2015

First Submission Date that Met QC Criteria

Sep 17, 2015

First Posted Date

Sep 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2018

Last Update Posted Date

Jan 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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?

Detailed 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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

81Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	single subcutaneous injection of placebo (normal saline)	Drug: placebo
Denosumab	Active Comparator	single subcutaneous injection of denosumab 60 mg	Drug: denosumab
young normal premenopausal women	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	subcutaneous saline injection	placebo	saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D012965	Sodium Chloride
D000069448	Denosumab

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals