NCT02467400

Brief Summary

This study is designed to answer the question as to whether the sympathetic nervous system is an important determinant of bone metabolism in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2015

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

June 4, 2015

Last Update Submit

February 4, 2019

Conditions

Osteoporosis, Age-Related

Keywords

bone formation

Outcome Measures

Primary Outcomes (1)

  • Ratio of serum bone formation to bone resorption marker

    Serum bone formation marker (PINP)/serum bone resorption marker (CTX)

    20 weeks

Study Arms (5)

placebo

PLACEBO COMPARATOR

Sugar pill 2/day for 20 weeks; The once daily groups will receive a placebo as the second dose

Drug: placebo

Atenolol

ACTIVE COMPARATOR

Atenolol 50 mg 1/day for 20 weeks

Drug: Atenolol

Nebivolol

ACTIVE COMPARATOR

Nebivolol 5 mg/day for 20 weeks

Drug: Nebivolol

Propranolol 40 mg

ACTIVE COMPARATOR

Propranolol 20 mg bid for 20 weeks

Drug: Propranolol

Propranolol 80 mg

ACTIVE COMPARATOR

Propranolol 40 mg bid for 20 weeks

Drug: Propranolol

Interventions

AtenololDRUG

beta blocker

Atenolol
NebivololDRUG

beta blocker

Nebivolol
PropranololDRUG

beta blocker

Propranolol 40 mgPropranolol 80 mg
placeboDRUG

placebo

placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Khosla S, Drake MT, Volkman TL, Thicke BS, Achenbach SJ, Atkinson EJ, Joyner MJ, Rosen CJ, Monroe DG, Farr JN. Sympathetic beta1-adrenergic signaling contributes to regulation of human bone metabolism. J Clin Invest. 2018 Nov 1;128(11):4832-4842. doi: 10.1172/JCI122151. Epub 2018 Oct 2.

    PMID: 30153111DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

AtenololNebivololPropranolol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesEthanolaminesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

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
Professor of Medicine and Physiology, College of Medicine

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 10, 2015

Study Start

July 1, 2015

Primary Completion

October 26, 2017

Study Completion

April 1, 2018

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)