NCT01724489

Brief Summary

Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable obesity

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

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 17, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

5.3 years

First QC Date

November 7, 2012

Results QC Date

November 15, 2019

Last Update Submit

December 4, 2019

Conditions

ObesityOsteopenia

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density

    Change in BMD over 18 months in the GH vs placebo group

    baseline and 18 months

Study Arms (2)

Growth Hormone

ACTIVE COMPARATOR

Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.

Drug: Growth hormone

Placebo

PLACEBO COMPARATOR

Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.

Drug: Placebo

Interventions

Growth hormoneDRUG
Also known as: Genotropin (Pfizer Inc.)
Growth Hormone
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-65 and generally healthy
  • BMI ≥ 25 kg/m2
  • Bone mineral density (BMD) T score ≤ -1.0 and \> -2.5 (as measured by DXA)

You may not qualify if:

  • For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
  • History of diabetes mellitus, cancer or other serious chronic disease
  • Use of osteoporosis medications
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

ObesityBone Diseases, Metabolic

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

Study medication was discontinued at 18 months. Subjects were followed for an additional 6 months off of study medication. The data reported here are for the primary 18-month trial.

Results Point of Contact

Title
Dr. Karen K. Miller
Organization
Massachusetts General Hospital
kkmiller@mgh.harvard.edu
617-726-3870

Study Officials

  • Karen Miller, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Miriam Bredella, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Neuroendocrine Unit

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

August 1, 2013

Primary Completion

November 15, 2018

Study Completion

April 1, 2019

Last Updated

December 17, 2019

Results First Posted

December 17, 2019

Record last verified: 2019-12

Locations

US(1)