AmenorrheaPhase 3838NCT00827151
Bone Mass Accrual in Adolescent Athletes
A Phase 3 study testing Estrogen in people with Amenorrhea and Bone Loss, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Read more about this study
- Who is it for?
- Ages 18 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amenorrhea, Bone Loss
- What is being tested?
- Estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jan 2015
- Phase
- Phase 3
- 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 18 to 21 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18-21 years of age
- Hypothalamic amenorrhea
- Greater than or equal to 15 years bone age
- BMI between 10th-90th percentiles for age
Who cannot join
- Use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these)
- Presence of anorexia nervosa or %IBW of < 85% based on the 50th %ile of BMI for age
- Spine BMD Z-score < -3
- Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)
- Conditions other than endurance training that may cause bone metabolism to be affected
- Abnormal TSH, elevated FSH, hematocrit < 30%
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- Pregnancy
- For girls with AA (to be randomized to estrogen and progesterone or no treatment)
- History of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal genital bleeding, known, suspected or history of breast or genital cancer or estrogen dependent neoplasia, known hypersensitivity to progesterone or estrogen or other product ingredients, liver dysfunction or disease
- LFTs greater than 1.5 times the upper limit of normal
- Family history or personal history of conditions that may increase risk of thromboembolism:
- Family history of myocardial infarction or strokes occurring at less than 50 years
- Family history of clotting disorders: normal coagulation profile will be necessary for enrollment
- History of smoking >10 cigarettes a day (history of smoking >14 cigarettes a day is a contraindication for estrogen, but we will be more conservative in our exclusion criteria)
- Personal history of blood clots
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: "2008P-00346: Bone Mass Accrual in Adolescent Athletes"
The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.
Read the detailed description
Young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. Bone density and structure will be assessed over this period. Hormonal evaluations will also be performed.
- Conditions
- Amenorrhea, Bone Loss
- Being tested
- Estrogen
- Keywords
- amenorrhea, athletes, bone loss, eumenorrhea
- Medical subject headings
- Amenorrhea, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Also called Vivelle-Dot, Prometrium
Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication
| Study group | Role | What they receive |
|---|---|---|
| Estrogen and lifestyle | Active comparator | Not described Receives: Drug: Estrogen |
| Lifestyle | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2011
- Study completionJan 2015 (estimated)
Why it stopped: The study was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies 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 3
- 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
- Madhu Misra, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827151
- Sponsor's protocol ID
- 2008P00246
- Other IDs
- NIH-HCNRC
- Acronym
- 838
- Status last verified
- Oct 2021
- First submitted
- 16 Jan 2009
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- "2008P-00346: Bone Mass Accrual in Adolescent Athletes"
- ClinicalTrials.gov ID
- NCT00827151
- Acronym / sponsor ID
- 838 / 2008P00246
- Conditions
- Amenorrhea, Bone Loss
- Keywords
- amenorrhea, athletes, bone loss, eumenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 22 Jan 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.
The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.
Detailed description
Young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. Bone density and structure will be assessed over this period. Hormonal evaluations will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen and lifestyle | Active comparator | Drug: Estrogen |
| Lifestyle | No intervention | – |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- 18-21 years of age
- Hypothalamic amenorrhea
- Greater than or equal to 15 years bone age
- BMI between 10th-90th percentiles for age
Key exclusion criteria (15 listed)
- Use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these)
- Presence of anorexia nervosa or %IBW of < 85% based on the 50th %ile of BMI for age
- Spine BMD Z-score < -3
- Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)
- Conditions other than endurance training that may cause bone metabolism to be affected
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 |
|---|---|---|
| EstrogenAlso: Vivelle-Dot, PrometriumEstrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication | Drug | Estrogen and lifestyle |
Primary outcome
Bone density
Time frame: One year
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.
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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.
Madhu Misra, MD, MPH 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 3 study testing Estrogen in people with Amenorrhea and Bone Loss, 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 5 inclusion and 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 density (time frame: One year). 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 26 Oct 2021.