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Study of Growth Hormone and Bone in Obesity

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ClinicalTrials.gov Identifier: NCT01724489
Recruitment Status : Active, not recruiting
First Posted : November 9, 2012
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

November 7, 2012
November 9, 2012
October 11, 2017
August 2013
November 2018   (Final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: baseline and 18 months ]
Change in BMD over 18 months in the GH vs placebo group
  • Bone Mineral Density [ Time Frame: baseline and 18 months ]
    Change in BMD over 18 months in the GH vs placebo group
  • Bone Marrow Fat [ Time Frame: baseline and 18 months ]
    Change in bone marrow fat in the GH vs placebo group
Complete list of historical versions of study NCT01724489 on ClinicalTrials.gov Archive Site
Not Provided
  • Bone Microarchitectural parameters [ Time Frame: baseline and 18 months ]
  • Bone Strength [ Time Frame: baseline and 18 months ]
    by finite element method (FEA)
  • Preadipocyte factor 1 (Pref-1) [ Time Frame: Baseline and 18 months ]
  • Bone formation markers [ Time Frame: baseline and 18 months ]
    aminoterminal propeptide of type I collagen (P1NP), undercarboxylated osteocalcin (ucOC)
  • Fasting and 2-hour oral glucose tolerance test (OGTT) insulin [ Time Frame: baseline and 18 months ]
  • Inflammatory Markers [ Time Frame: baseline and 18 months ]
    high-sensitivity C-reactive protein(hsCRP), Tumor necrosis factor (TNF) receptor 1 and Interleukin-6 (IL-6). We have shown a decrease in hsCRP with GH administration x 6 months associated with an increase in P1NP in obesity. Others have shown that TNF alpha receptor 1 and IL-6 stimulate osteoclasts and are associated with increased fracture risk.
  • Serum lipoproteins [ Time Frame: baseline and 18 months ]
    Our preliminary data demonstrate a decrease in Apolipoprotein B (ApoB) associated with an increase in bone formation with GH x 6 months in obesity.
  • 25-hydroxy (25-OH) vitamin D [ Time Frame: baseline and 18 months ]
    Our preliminary data show an increase in 25-OH vitamin D with GH x 6 months in obesity.
Not Provided
Not Provided
 
Study of Growth Hormone and Bone in Obesity
Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
  • Obesity
  • Osteopenia
  • Drug: Growth hormone
    Other Name: Genotropin (Pfizer Inc.)
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
April 2019
November 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01724489
2012P002276
Yes
Not Provided
Not Provided
Karen Klahr Miller, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institutes of Health (NIH)
  • Pfizer
Principal Investigator: Karen Miller, MD Massachusetts General Hospital
Principal Investigator: Miriam Bredella, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2017

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