Trial Outcomes & Findings for Study of Growth Hormone and Bone in Obesity (NCT NCT01724489)

NCT ID: NCT01724489

Last Updated: 2019-12-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: baseline and 18 months
• Results posted on: 2019-12-17

Participant Flow

Subjects were recruited from August 2013 to April 2017. Recruitment techniques included posting advertisements on the internet (i.e. Facebook and Craigslist) and on the Massachusetts General Hospital's clinical trial recruitment website.

Of the 253 people who signed a consent form, 165 were unable to participate due to various reasons including meeting ineligibility criteria. The 88 subjects remaining were randomized to one of two arms. Of these 88 subjects, a total of 77 subjects had baseline measurements collected.

Participant milestones

Measure	Growth Hormone Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Overall Study STARTED	39	38
Overall Study COMPLETED	23	26
Overall Study NOT COMPLETED	16	12

Reasons for withdrawal

Measure	Growth Hormone Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Overall Study Adverse Event	8	3
Overall Study Surgery, medication	1	1
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	6	6

Baseline Characteristics

Study of Growth Hormone and Bone in Obesity

Baseline characteristics by cohort

Measure	Growth Hormone n=39 Participants 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. Growth hormone	Placebo n=38 Participants Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. Placebo	Total n=77 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 13 • n=5 Participants	49 years STANDARD_DEVIATION 12 • n=7 Participants	48 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	30 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 18 months

Population: Two subjects from the growth hormone arm were not analyzed due to large amount of weight loss, which has a well-documented effect of decreasing BMD. AP spine bone density in one study subject in the placebo group was excluded because the scan was technically poor. These data were excluded before the study was unblinded.

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

Outcome measures

Measure	Growth Hormone n=21 Participants Growth Hormone (GH) is Genotropin, provided by Pfizer Inc. It is a self-administered sub-cutaneous daily injection using an injection pen device. It was administered up to 18 months. The dose was titrated based on IGF-1 hormone levels with the goal of maintaining an IGF-1 level in the upper-quartile of the normal range.	Placebo n=25 Participants Placebo was provided by Pfizer Inc. It appeared identical to active growth hormone and was administered in the same manner; self administered sub-cutaneous daily for 18 months using an injection pen device. Dose was titrated in a way to maintain the double-blind.
Bone Mineral Density	-0.015 grams/cm^2 Standard Deviation 0.033	-0.008 grams/cm^2 Standard Deviation 0.034

Adverse Events

Growth Hormone

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Growth Hormone n=39 participants at risk 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. Growth hormone	Placebo n=38 participants at risk Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. Placebo
Psychiatric disorders prolonged inpatient psychiatric hospitalization	0.00% 0/39 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	2.6% 1/38 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.

Other adverse events

Measure	Growth Hormone n=39 participants at risk 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. Growth hormone	Placebo n=38 participants at risk Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. Placebo
General disorders headache	2.6% 1/39 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	5.3% 2/38 • Number of events 3 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Blood and lymphatic system disorders edema (swelling) in the hands and/or feet	20.5% 8/39 • Number of events 11 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	15.8% 6/38 • Number of events 6 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders pain and/or stiffness in the hands and/or feet	23.1% 9/39 • Number of events 10 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	2.6% 1/38 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders joint pain	12.8% 5/39 • Number of events 5 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	2.6% 1/38 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Nervous system disorders tingling	33.3% 13/39 • Number of events 16 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	7.9% 3/38 • Number of events 4 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders myalgia (muscle aches)	17.9% 7/39 • Number of events 7 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	7.9% 3/38 • Number of events 3 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders carpal tunnel syndrome	2.6% 1/39 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	0.00% 0/38 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Metabolism and nutrition disorders elevated blood sugar	12.8% 5/39 • Number of events 5 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	5.3% 2/38 • Number of events 2 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Skin and subcutaneous tissue disorders injection site discomfort	5.1% 2/39 • Number of events 2 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	2.6% 1/38 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Skin and subcutaneous tissue disorders injection site bruising	0.00% 0/39 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	2.6% 1/38 • Number of events 1 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.
Musculoskeletal and connective tissue disorders joint stiffness (not in the hands and/or feet)	5.1% 2/39 • Number of events 2 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.	0.00% 0/38 • 18 months Growth hormone (Pfizer) is FDA approved and has a possible side-effect profile described/listed in the medication package insert. The investigators recorded all adverse events (as defined by the clinicaltrials.gov definition) and categorized them by "expected" (eg listed in the medication package insert) and "unexpected" (not listed in the medication package insert). \# of events = # of subjects that experienced the side effect at any point during the study.

Additional Information

Dr. Karen K. Miller

Massachusetts General Hospital

Phone: 617-726-3870

Email: kkmiller@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place