Bone MetabolismPhase 2NCT00853502
The Effect of Testosterone Replacement on Bone Mineral Density in Boys and Men With Anorexia Nervosa
A Phase 2 study testing testosterone cypionate in people with Bone Metabolism, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Decreased bone strength is a common and serious medical problem present in many people with anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as testosterone. Low testosterone levels have been shown to result in low bone density. Read more about this study
- Who is it for?
- Ages 14 to 30 years, men only
- Conditions the study is for
- Bone Metabolism
- What is being tested?
- testosterone cypionate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Anorexia Nervosa
- Teenage boys and young adult men, age 14-30 years
- Hypogonadism indicated by a testosterone level within the lower 25th percentile for pubertal stage or below normal for pubertal stage
Who cannot join
- Disease or illness known to affect bone metabolism
- Use of medications known to affect bone metabolism, such as corticosteroids or androgenic steroids, within 3 months of study initiation
- Subjects with a z-score less than -2.5 on DXA secondary to concerns of severely low bone mineral density which may require aggressive monitoring
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa
Decreased bone strength is a common and serious medical problem present in many people with anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as testosterone. Low testosterone levels have been shown to result in low bone density.
We are investigating whether bone mineral density and bone microarchitecture are abnormal in males with anorexia nervosa and whether supplementation with testosterone would improve both bone mineral density and bone microarchitecture.
Read the detailed description
Low bone mineral density is a co-morbidity associated with anorexia nervosa that has been shown to persist even after weight gain. Peak bone mass accrual occurs during the adolescent years, and a disruption in this critical process increases the risk for developing persistent deficits in bone density, and possibly increased fracture risk. Multiple variables contribute to the bone mass accrual process in puberty including adequate levels of sex hormones and puberty specific changes in levels of these hormones. Teenage boys with anorexia nervosa have lower bone density than normal weight boys of comparable maturity, and also have decreased levels of testosterone, as well as estradiol, when compared with healthy controls. Although testosterone is an important predictor of bone density in males with anorexia nervosa, the effect of testosterone replacement on bone mass accrual and bone microarchitecture in hypogonadal teenage boys and young adult men with anorexia nervosa is unknown. We hypothesize both bone mass and bone microarchitecture are abnormal in anorexia nervosa and that testosterone replacement in adolescent males with anorexia nervosa will improve both bone mass and microarchitecture.
- Conditions
- Bone Metabolism
- Being tested
- testosterone cypionate
- Keywords
- anorexia nervosa, testosterone, disordered eating, hypogonadism, bone
- Medical subject headings
- Anorexia Nervosa, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone cypionateDrug
dose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months
| Study group | Role | What they receive |
|---|---|---|
| testosterone cypionate | Active comparator | Not described Receives: Drug: testosterone cypionate |
| bone monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone metabolism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone MetabolismStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhusmita Misra, Massachusetts General Hospital
- Investigators
- Madhusmita Misra, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853502
- Sponsor's protocol ID
- 2008P-001902
- Status last verified
- Oct 2021
- First submitted
- 26 Feb 2009
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Misra M, Katzman DK, Cord J, Manning SJ, Mendes N, Herzog DB, Miller KK, Klibanski A. Bone metabolism in adolescent boys with anorexia nervosa. J Clin Endocrinol Metab. 2008 Aug;93(8):3029-36. doi: 10.1210/jc.2008-0170. Epub 2008 Jun 10.
PubMed 18544623
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Testosterone Replacement on Bone Mineral Density and Bone Microarchitecture in Teenage Boys and Young Adult Men With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00853502
- Acronym / sponsor ID
- 2008P-001902
- Conditions
- Bone Metabolism
- Keywords
- anorexia nervosa, testosterone, disordered eating, hypogonadism, bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
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 common and serious medical problem present in many people with anorexia nervosa. Men with anorexia nervosa have lower levels of gonadal steroids such as testosterone. Low testosterone levels have been shown to result in low bone density.
We are investigating whether bone mineral density and bone microarchitecture are abnormal in males with anorexia nervosa and whether supplementation with testosterone would improve both bone mineral density and bone microarchitecture.
Detailed description
Low bone mineral density is a co-morbidity associated with anorexia nervosa that has been shown to persist even after weight gain. Peak bone mass accrual occurs during the adolescent years, and a disruption in this critical process increases the risk for developing persistent deficits in bone density, and possibly increased fracture risk. Multiple variables contribute to the bone mass accrual process in puberty including adequate levels of sex hormones and puberty specific changes in levels of these hormones. Teenage boys with anorexia nervosa have lower bone density than normal weight boys of comparable maturity, and also have decreased levels of testosterone, as well as estradiol, when compared with healthy controls. Although testosterone is an important predictor of bone density in males with anorexia nervosa, the effect of testosterone replacement on bone mass accrual and bone microarchitecture in hypogonadal teenage boys and young adult men with anorexia nervosa is unknown. We hypothesize both bone mass and bone microarchitecture are abnormal in anorexia nervosa and that testosterone replacement in adolescent males with anorexia nervosa will improve both bone mass and microarchitecture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone cypionate | Active comparator | Drug: testosterone cypionate |
| bone monitoring | No intervention | – |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Anorexia Nervosa
- Teenage boys and young adult men, age 14-30 years
- Hypogonadism indicated by a testosterone level within the lower 25th percentile for pubertal stage or below normal for pubertal stage
Key exclusion criteria (3 listed)
- Disease or illness known to affect bone metabolism
- Use of medications known to affect bone metabolism, such as corticosteroids or androgenic steroids, within 3 months of study initiation
- Subjects with a z-score less than -2.5 on DXA secondary to concerns of severely low bone mineral density which may require aggressive monitoring
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 |
|---|---|---|
| testosterone cypionatedose dependent on pubertal stage, intramuscular injection once every 3 weeks for 12 months | Drug | testosterone cypionate |
Primary outcome
bone metabolism
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 18544623Misra M, Katzman DK, Cord J, Manning SJ, Mendes N, Herzog DB, Miller KK, Klibanski A. Bone metabolism in adolescent boys with anorexia nervosa. J Clin Endocrinol Metab. 2008 Aug;93(8):3029-36. doi: 10.1210/jc.2008-0170. Epub 2008 Jun 10.
Related trials for Bone Metabolism
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
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.
Madhusmita Misra, 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 testosterone cypionate in people with Bone Metabolism, 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Oct 2021. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00853502, which also lists 1 linked publication.
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 26 Oct 2021.