Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00827151
Status:
WITHDRAWN
Last Update Posted:
2021-10-26
First Post:
2009-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Mass Accrual in Adolescent Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000568', 'term': 'Amenorrhea'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone density', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amenorrhea', 'athletes', 'bone loss', 'eumenorrhea'], 'conditions': ['Amenorrhea', 'Bone Loss']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18-21 years of age\n* Hypothalamic amenorrhea\n* Greater than or equal to 15 years bone age\n* BMI between 10th-90th percentiles for age\n\nExclusion Criteria:\n\n* 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)\n* Presence of anorexia nervosa or %IBW of \\< 85% based on the 50th %ile of BMI for age\n* Spine BMD Z-score \\< -3\n* Conditions other than endurance training that may cause amenorrhea including PCOS (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)\n* Conditions other than endurance training that may cause bone metabolism to be affected\n* Abnormal TSH, elevated FSH, hematocrit \\< 30%\n* Pregnancy\n\nFor girls with AA (to be randomized to estrogen and progesterone or no treatment)\n\n* 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\n* LFTs greater than 1.5 times the upper limit of normal\n* Family history or personal history of conditions that may increase risk of thromboembolism:\n\n 1. Family history of myocardial infarction or strokes occurring at less than 50 years\n 2. Family history of clotting disorders: normal coagulation profile will be necessary for enrollment\n* 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)\n* Personal history of blood clots'}, 'identificationModule': {'nctId': 'NCT00827151', 'acronym': '838', 'briefTitle': 'Bone Mass Accrual in Adolescent Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': '"2008P-00346: Bone Mass Accrual in Adolescent Athletes"', 'orgStudyIdInfo': {'id': '2008P00246'}, 'secondaryIdInfos': [{'id': 'NIH-HCNRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Estrogen and lifestyle', 'interventionNames': ['Drug: Estrogen']}, {'type': 'NO_INTERVENTION', 'label': 'Lifestyle'}], 'interventions': [{'name': 'Estrogen', 'type': 'DRUG', 'otherNames': ['Vivelle-Dot', 'Prometrium'], 'description': 'Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication', 'armGroupLabels': ['Estrogen and lifestyle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Madhu Misra, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Pediatrics', 'investigatorFullName': 'Madhusmita Misra', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}