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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Study of Growth Hormone and Bone in Obesity

NCTNCT01724489 (opens ClinicalTrials.gov in a new tab)Other id2012P002276
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
77 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Aug 2013
Primary completion
15 Nov 2018
Completion
1 Apr 2019
First posted
9 Nov 2012 (estimated)
Last update posted
17 Dec 2019
Conditions
Obesity · Osteopenia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201620182020
  1. N/A

    Study of Growth Hormone and Bone in Obesity

    NCT01724489

    Aug 2013 to 1 Apr 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Growth hormoneDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Growth Hormone

    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.

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bone Mineral Density

    Time frame · baseline and 18 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline and 18 months

Bone Mineral Density

GroupValue (grams/cm^2)Spread
Growth Hormone-0.0150.033
Placebo-0.0080.034

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Growth HormoneGrowth 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. Growth hormone0 / 390 / 3929 / 39
PlaceboPlacebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. Placebo0 / 381 / 3813 / 38

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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) Exclusion Criteria: * 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

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