NCT02554695

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2016

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

September 17, 2015

Last Update Submit

January 3, 2018

Conditions

Bone LossAging

Keywords

adrenergic

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Osteoclast-osteoblast coupling factor changes

    3 months

Study Arms (3)

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

placeboDRUG

subcutaneous saline injection

Also known as: saline
placebo
denosumabDRUG

single subcutaneous injection of denosumab 60 mg

Also known as: Prolia
Denosumab

Eligibility Criteria

Age25 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Sodium ChlorideDenosumab

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sundeep Khosla, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 17, 2015

First Posted

September 18, 2015

Study Start

October 20, 2015

Primary Completion

October 25, 2016

Study Completion

October 25, 2016

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

US(1)