Study of Growth Hormone and Bone in Obesity

NCT01724489

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity, Osteopenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Obesity, OsteopeniaStudy of Growth Hormone and Bone in Obesity
NCT01724489
  1. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Growth Hormone and Bone in Obesity
Official Title  ICMJE Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Obesity
  • Osteopenia
Intervention  ICMJE
  • Drug: Growth hormone
    Other Name: Genotropin (Pfizer Inc.)
  • Drug: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Growth hormone
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2019)
77
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2012)
75
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01724489
Other Study ID Numbers  ICMJE 2012P002276
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karen Klahr Miller, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Karen Miller, MDMassachusetts General Hospital
Principal Investigator:Miriam Bredella, MDMassachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP