Anorexia NervosaPhase 2NCT00283595
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
A Phase 2 study testing Recombinant Human Growth Hormone in people with Anorexia Nervosa and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa, Osteopenia, Osteoporosis
- What is being tested?
- Recombinant Human Growth Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- women between 14 to 45 years with anorexia nervosa
Who cannot join
- pregnancy
- previous history of malignancy.
- oral contraceptive pills or other hormones within last 8 - 12 weeks
- medications known to affect bone within last 12 weeks
- fracture within last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusettes General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.
We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.
Read the detailed description
- Twelve week study
- Eight visits, six of which can be conducted at your home physician's office
- Two bone density scans
- Hormonal and nutritional evaluations
- Conditions
- Anorexia Nervosa, Osteopenia, Osteoporosis, Eating Disorders
- Being tested
- Recombinant Human Growth Hormone, Placebo for Recombinant Human Growth Hormone
- Keywords
- Anorexia Nervosa, Eating disorder, Bone, Growth hormone, Osteopenia, Osteoporosis
- Medical subject headings
- Anorexia Nervosa, Bone Diseases, Metabolic, Osteoporosis, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Growth HormoneDrug
Also called Nutropin AQ
Dosage increased in steps for first four weeks. Self injection qd x 12 weeks
Placebo for Recombinant Human Growth HormoneDrug
Also called Placebo for Nutropin AQ
Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment with rHGH Receives: Drug: Recombinant Human Growth Hormone |
| 2 | Placebo comparator | Treatment with Placebo Receives: Drug: Placebo for Recombinant Human Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Metabolism
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
Measured: Baseline, 12 weeks
Secondary outcomes (1)
IGF-1 Level
Change in IGF-1 level between baseline and 12 weeks
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne Klibanski, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283595
- Sponsor's protocol ID
- 2005-P-001443/3; MGH
- Status last verified
- Aug 2020
- First submitted
- 27 Jan 2006
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supraphysiological rhGH on Bone Metabolism in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00283595
- Acronym / sponsor ID
- 2005-P-001443/3; MGH
- Conditions
- Anorexia Nervosa, Osteopenia, Osteoporosis, Eating Disorders
- Keywords
- Anorexia Nervosa, Eating disorder, Bone, Growth hormone, Osteopenia, Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Jan 2006 (estimated)
- Results
- Posted 16 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength.
We are investigating whether a hormone that is naturally produced by the human body, called growth hormone, can help strengthen the bones of women with this type of disordered eating.
Detailed description
- Twelve week study
- Eight visits, six of which can be conducted at your home physician's office
- Two bone density scans
- Hormonal and nutritional evaluations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Recombinant Human Growth HormoneTreatment with rHGH |
| 2 | Placebo comparator | Drug: Placebo for Recombinant Human Growth HormoneTreatment with Placebo |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- women between 14 to 45 years with anorexia nervosa
Key exclusion criteria (5 listed)
- pregnancy
- previous history of malignancy.
- oral contraceptive pills or other hormones within last 8 - 12 weeks
- medications known to affect bone within last 12 weeks
- fracture within last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Growth HormoneAlso: Nutropin AQDosage increased in steps for first four weeks. Self injection qd x 12 weeks | Drug | 1 |
| Placebo for Recombinant Human Growth HormoneAlso: Placebo for Nutropin AQAdministered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks | Drug | 2 |
Primary outcome
Bone Metabolism
Time frame: Baseline, 12 weeks
Change in the marker of bone formation, N-terminal pro peptide of type 1 procollagen (P1NP) levels, between baseline and 12 weeks
1 secondary outcome
IGF-1 Level
Time frame: Baseline, 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Klibanski, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Growth Hormone in people with Anorexia Nervosa and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Metabolism (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.