Anorexia NervosaPhase 2/3NCT00310791
Adrenal and Gonadal Hormone Replacement in Anorexia Nervosa
A Phase 2/3 study testing Hormone replacement therapy (estrogen/progestin) and Dehydroepiandrosterone (DHEA) in people with Anorexia Nervosa, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy… Read more about this study
- Who is it for?
- Ages 15 to 30 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Hormone replacement therapy (estrogen/progestin) and Dehydroepiandrosterone (DHEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2010
- Phase
- Phase 2/3
- 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 15 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15 - 30 years
- Anorexia nervosa by psychiatric criteria
- Amenorrhea for at least 3 months
Who cannot join
- Receiving no medications known to affects bone metabolism
- No other chronic medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Effects of Adrenal and Gonadal Hormone Replacement in Young Women With Anorexia Nervosa
This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine the effects of an 18-month treatment course on bone mass, circulating markers of bone turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also studying if these therapies change bone structure to increase skeletal strength compared to placebo, as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry (DXA).
Read the detailed description
Profound osteopenia is a frequent and often irreversible complication of anorexia nervosa (AN). Adolescents with AN often have a reduced peak bone mass and are at increased risk for early osteoporosis and fractures. These young women have subnormal serum levels of gonadal steroids and the adrenal androgen dehydroepiandrosterone (DHEA) that may be associated with their low bone mineral density (BMD). Low DHEA levels are accompanied by decreased levels of insulin-like growth factor I (IGF-I), estrogen, and testosterone. Previous data from our group indicate that oral DHEA therapy in young women with AN: increases lean body mass, serum levels of bone formation markers and insulin-like growth factor I (IGF-I), and decreases urinary markers of bone resorption. We also found that standard hormonal replacement therapy (HRT) significantly decreased bone resorption markers. Information on the effects of these therapies on bone strength and ultimate fracture risk is lacking.
In this project, we will test the hypothesis that combined therapy with DHEA and estrogen/progestin will enhance bone mass in patients with AN through anabolic and antiosteolytic mechanisms. We will test the hypothesis that 18 months of DHEA + HRT will increase bone mineral density (BMD) and markers of bone formation, while decreasing bone resorption markers in these patients. The proposed study will examine whether restoring normal levels of DHEA and estrogen in these young women will increase bone mass during a critical period for bone accretion. The study will also examine whether DHEA's anabolic effects on bone are mediated through the skeletal IGF-I regulatory system. Using cross-sectional analyses of dual energy x-ray absorptiometry (DXA) data, we will also measure indices of bone structural geometry to determine if mechanical strength is compromised in these young women, and if strength is restored in response to combined anabolic/antiresorptive therapy.
To gain new information on the mechanisms underlying bone loss and fracture risk in young women with AN, our research goals are:
Specific Aim I: Through a randomized controlled trial, to measure the effects of an 18-month course of DHEA + HRT on bone mass, markers of bone turnover, and serum levels of IGF-I compared to placebo. Specific Aim II: To determine whether combined therapy with adrenal and gonadal steroid replacement changes bone structure to increase strength compared to placebo, as assessed through cross-sectional geometric analysis of DXA data.
- Conditions
- Anorexia Nervosa
- Being tested
- Hormone replacement therapy (estrogen/progestin), Placebo (Sugar Pill), Dehydroepiandrosterone (DHEA)
- Keywords
- anorexia nervosa, adolescents, dual-energy x-ray absorptiometry, dehydroepiandrosterone (DHEA), osteoporosis
- Medical subject headings
- Anorexia Nervosa, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone replacement therapy (estrogen/progestin)Drug
Also called Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel), Premarin (conjugated estrogens)
Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel)
Placebo (Sugar Pill)Other
Also called Placebo, Sugar pill
Placebo (sugar pill)
Dehydroepiandrosterone (DHEA)Drug
Also called Prasterone
50 mg tablet, 1 daily
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | Placebo (sugar pill); identical to treatment medication capsule Receives: Other: Placebo (Sugar Pill) |
| DHEA + Hormone replacement therapy (estrogen/progestin) | Experimental | Combined therapy of dehydroepiandrosterone (DHEA) and hormone replacement therapy (ERT). Patients randomized to the DHEA + HRT arm will receive micronized oral DHEA in a dose of 50 mg daily + HRT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel for 15 months). The estrogen/progestin component of the regimen has been chosen to maximize patient compliance, as patients with AN may experience bloating or nausea if higher estrogen doses (> 20 g) are initiated too rapidly. The DHEA capsule strength will be 50 mg, the total daily dose to be studied in combination with HRT. The micronized DHEA preparation achieves more constant DHEA and DHEA-S levels. Fifty milligrams appears to be a physiological replacement dose for these young women, determined both from our pilot (10) and longitudinal studies (7). Receives: Drug: Hormone replacement therapy (estrogen/progestin); Drug: Dehydroepiandrosterone (DHEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Areal Bone Density by DXA
Measured: 18-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startApr 2004
- Primary completionOct 2009
- Study completionDec 2010
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Boston Children's 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Catherine M. Gordon, Boston Children's Hospital
- Investigators
- Catherine M. Gordon, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310791
- Sponsor's protocol ID
- Anorexia04
- Other IDs
- R01HD043869
- Status last verified
- Mar 2018
- First submitted
- 3 Apr 2006
- Last updated
- 11 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vajapeyam S, Ecklund K, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Rosen CJ, Gordon CM. Magnetic resonance imaging and spectroscopy evidence of efficacy for adrenal and gonadal hormone replacement therapy in anorexia nervosa. Bone. 2018 May;110:335-342. doi: 10.1016/j.bone.2018.02.021. Epub 2018 Feb 26.
PubMed 29496516Divasta AD, Feldman HA, Brown JN, Giancaterino C, Holick MF, Gordon CM. Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa. J Clin Endocrinol Metab. 2011 Aug;96(8):2575-80. doi: 10.1210/jc.2011-0243. Epub 2011 Jun 1.
PubMed 21632810Divasta AD, Feldman HA, Gordon CM. Vertebral fracture assessment in adolescents and young women with anorexia nervosa: a case series. J Clin Densitom. 2014 Jan-Mar;17(1):207-11. doi: 10.1016/j.jocd.2013.02.011. Epub 2013 Apr 3.
PubMed 23562364DiVasta AD, Feldman HA, Beck TJ, LeBoff MS, Gordon CM. Does hormone replacement normalize bone geometry in adolescents with anorexia nervosa? J Bone Miner Res. 2014 Jan;29(1):151-7. doi: 10.1002/jbmr.2005.
PubMed 23744513DiVasta AD, Mulkern RV, Gordon CM, Ecklund K. MR Imaging in a case of severe anorexia nervosa: the 'flip-flop' effect. Pediatr Radiol. 2015 Apr;45(4):617-20. doi: 10.1007/s00247-014-3145-3. Epub 2014 Aug 17.
PubMed 25129340Donaldson AA, Feldman HA, O'Donnell JM, Gopalakrishnan G, Gordon CM. Spinal Bone Texture Assessed by Trabecular Bone Score in Adolescent Girls With Anorexia Nervosa. J Clin Endocrinol Metab. 2015 Sep;100(9):3436-42. doi: 10.1210/jc.2015-2002. Epub 2015 Jun 24.
PubMed 26108094DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Effect of Exercise and Antidepressants on Skeletal Outcomes in Adolescent Girls With Anorexia Nervosa. J Adolesc Health. 2017 Feb;60(2):229-232. doi: 10.1016/j.jadohealth.2016.10.003. Epub 2016 Dec 6.
PubMed 27939877DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Skeletal outcomes by peripheral quantitative computed tomography and dual-energy X-ray absorptiometry in adolescent girls with anorexia nervosa. Osteoporos Int. 2016 Dec;27(12):3549-3558. doi: 10.1007/s00198-016-3685-5. Epub 2016 Jul 8.
PubMed 27392467Bialo SR, Gordon CM. Underweight, overweight, and pediatric bone fragility: impact and management. Curr Osteoporos Rep. 2014 Sep;12(3):319-28. doi: 10.1007/s11914-014-0226-z.
PubMed 24986712Ecklund K, Vajapeyam S, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Gordon CM. Bone marrow fat content in 70 adolescent girls with anorexia nervosa: Magnetic resonance imaging and magnetic resonance spectroscopy assessment. Pediatr Radiol. 2017 Jul;47(8):952-962. doi: 10.1007/s00247-017-3856-3. Epub 2017 Apr 22.
PubMed 28432403
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adrenal and Gonadal Hormone Replacement in Young Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00310791
- Acronym / sponsor ID
- Anorexia04
- Conditions
- Anorexia Nervosa
- Keywords
- anorexia nervosa, adolescents, dual-energy x-ray absorptiometry, dehydroepiandrosterone (DHEA), osteoporosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Posted 1 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to gain new information on why young women with anorexia nervosa are predisposed to early bone loss and osteoporosis. Through a randomized treatment trial in which participants will receive either combined therapy with the adrenal hormone, dehydroepiandrosterone (DHEA) and estrogen replacement therapy or placebo, we will determine the effects of an 18-month treatment course on bone mass, circulating markers of bone turnover, and serum levels of a factor, insulin-like growth factor I (IGF-I). We are also studying if these therapies change bone structure to increase skeletal strength compared to placebo, as assessed through cross-sectional geometric analysis of our bone density data by dual-energy x-ray absorptiometry (DXA).
Detailed description
Profound osteopenia is a frequent and often irreversible complication of anorexia nervosa (AN). Adolescents with AN often have a reduced peak bone mass and are at increased risk for early osteoporosis and fractures. These young women have subnormal serum levels of gonadal steroids and the adrenal androgen dehydroepiandrosterone (DHEA) that may be associated with their low bone mineral density (BMD). Low DHEA levels are accompanied by decreased levels of insulin-like growth factor I (IGF-I), estrogen, and testosterone. Previous data from our group indicate that oral DHEA therapy in young women with AN: increases lean body mass, serum levels of bone formation markers and insulin-like growth factor I (IGF-I), and decreases urinary markers of bone resorption. We also found that standard hormonal replacement therapy (HRT) significantly decreased bone resorption markers. Information on the effects of these therapies on bone strength and ultimate fracture risk is lacking.
In this project, we will test the hypothesis that combined therapy with DHEA and estrogen/progestin will enhance bone mass in patients with AN through anabolic and antiosteolytic mechanisms. We will test the hypothesis that 18 months of DHEA + HRT will increase bone mineral density (BMD) and markers of bone formation, while decreasing bone resorption markers in these patients. The proposed study will examine whether restoring normal levels of DHEA and estrogen in these young women will increase bone mass during a critical period for bone accretion. The study will also examine whether DHEA's anabolic effects on bone are mediated through the skeletal IGF-I regulatory system. Using cross-sectional analyses of dual energy x-ray absorptiometry (DXA) data, we will also measure indices of bone structural geometry to determine if mechanical strength is compromised in these young women, and if strength is restored in response to combined anabolic/antiresorptive therapy.
To gain new information on the mechanisms underlying bone loss and fracture risk in young women with AN, our research goals are:
Specific Aim I: Through a randomized controlled trial, to measure the effects of an 18-month course of DHEA + HRT on bone mass, markers of bone turnover, and serum levels of IGF-I compared to placebo. Specific Aim II: To determine whether combined therapy with adrenal and gonadal steroid replacement changes bone structure to increase strength compared to placebo, as assessed through cross-sectional geometric analysis of DXA data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Other: Placebo (Sugar Pill)Placebo (sugar pill); identical to treatment medication capsule |
| DHEA + Hormone replacement therapy (estrogen/progestin) | Experimental | Drug: Hormone replacement therapy (estrogen/progestin), Drug: Dehydroepiandrosterone (DHEA)Combined therapy of dehydroepiandrosterone (DHEA) and hormone replacement therapy (ERT). Patients randomized to the DHEA + HRT arm will receive micronized oral DHEA in a dose of 50 mg daily + HRT (0.3 mg Premarin, 1 tablet daily for 3 months, follow by Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel for 15 months). The estrogen/progestin component of the regimen has been chosen to maximize patient compliance, as patients with AN may experience bloating or nausea if higher estrogen doses (> 20 g) are initiated too rapidly. The DHEA capsule strength will be 50 mg, the total daily dose to be studied in combination with HRT. The micronized DHEA preparation achieves more constant DHEA and DHEA-S levels. Fifty milligrams appears to be a physiological replacement dose for these young women, determined both from our pilot (10) and longitudinal studies (7). |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 15 - 30 years
- Anorexia nervosa by psychiatric criteria
- Amenorrhea for at least 3 months
Key exclusion criteria (2 listed)
- Receiving no medications known to affects bone metabolism
- No other chronic medical conditions
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 |
|---|---|---|
| Hormone replacement therapy (estrogen/progestin)Also: Alesse (20 mg ethinyl estradiol + 0.1 mg levonorgestrel), Premarin (conjugated estrogens)Hormone replacement therapy (estrogen/progestin). 0.3 mg conjugated estrogens x 3 months, followed by 9 months of oral contraceptive (20 mg ethinyl estradiol + 0.1 mg levonorgestrel) | Drug | DHEA + Hormone replacement therapy (estrogen/progestin) |
| Placebo (Sugar Pill)Also: Placebo, Sugar pillPlacebo (sugar pill) | Other | Sugar Pill |
| Dehydroepiandrosterone (DHEA)Also: Prasterone50 mg tablet, 1 daily | Drug | DHEA + Hormone replacement therapy (estrogen/progestin) |
Primary outcome
Areal Bone Density by DXA
Time frame: 18-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29496516Vajapeyam S, Ecklund K, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Rosen CJ, Gordon CM. Magnetic resonance imaging and spectroscopy evidence of efficacy for adrenal and gonadal hormone replacement therapy in anorexia nervosa. Bone. 2018 May;110:335-342. doi: 10.1016/j.bone.2018.02.021. Epub 2018 Feb 26.
- Results publication: PubMed 21632810Divasta AD, Feldman HA, Brown JN, Giancaterino C, Holick MF, Gordon CM. Bioavailability of vitamin D in malnourished adolescents with anorexia nervosa. J Clin Endocrinol Metab. 2011 Aug;96(8):2575-80. doi: 10.1210/jc.2011-0243. Epub 2011 Jun 1.
- Results publication: PubMed 23562364Divasta AD, Feldman HA, Gordon CM. Vertebral fracture assessment in adolescents and young women with anorexia nervosa: a case series. J Clin Densitom. 2014 Jan-Mar;17(1):207-11. doi: 10.1016/j.jocd.2013.02.011. Epub 2013 Apr 3.
- Results publication: PubMed 23744513DiVasta AD, Feldman HA, Beck TJ, LeBoff MS, Gordon CM. Does hormone replacement normalize bone geometry in adolescents with anorexia nervosa? J Bone Miner Res. 2014 Jan;29(1):151-7. doi: 10.1002/jbmr.2005.
- Results publication: PubMed 25129340DiVasta AD, Mulkern RV, Gordon CM, Ecklund K. MR Imaging in a case of severe anorexia nervosa: the 'flip-flop' effect. Pediatr Radiol. 2015 Apr;45(4):617-20. doi: 10.1007/s00247-014-3145-3. Epub 2014 Aug 17.
- Results publication: PubMed 26108094Donaldson AA, Feldman HA, O'Donnell JM, Gopalakrishnan G, Gordon CM. Spinal Bone Texture Assessed by Trabecular Bone Score in Adolescent Girls With Anorexia Nervosa. J Clin Endocrinol Metab. 2015 Sep;100(9):3436-42. doi: 10.1210/jc.2015-2002. Epub 2015 Jun 24.
- Results publication: PubMed 27939877DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Effect of Exercise and Antidepressants on Skeletal Outcomes in Adolescent Girls With Anorexia Nervosa. J Adolesc Health. 2017 Feb;60(2):229-232. doi: 10.1016/j.jadohealth.2016.10.003. Epub 2016 Dec 6.
- Results publication: PubMed 27392467DiVasta AD, Feldman HA, O'Donnell JM, Long J, Leonard MB, Gordon CM. Skeletal outcomes by peripheral quantitative computed tomography and dual-energy X-ray absorptiometry in adolescent girls with anorexia nervosa. Osteoporos Int. 2016 Dec;27(12):3549-3558. doi: 10.1007/s00198-016-3685-5. Epub 2016 Jul 8.
- Results publication: PubMed 24986712Bialo SR, Gordon CM. Underweight, overweight, and pediatric bone fragility: impact and management. Curr Osteoporos Rep. 2014 Sep;12(3):319-28. doi: 10.1007/s11914-014-0226-z.
- Results publication: PubMed 28432403Ecklund K, Vajapeyam S, Mulkern RV, Feldman HA, O'Donnell JM, DiVasta AD, Gordon CM. Bone marrow fat content in 70 adolescent girls with anorexia nervosa: Magnetic resonance imaging and magnetic resonance spectroscopy assessment. Pediatr Radiol. 2017 Jul;47(8):952-962. doi: 10.1007/s00247-017-3856-3. Epub 2017 Apr 22.
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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.
Catherine M. Gordon, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hormone replacement therapy (estrogen/progestin) and Dehydroepiandrosterone (DHEA) in people with Anorexia Nervosa, run by Boston Children's 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 2 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 11 Apr 2018. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 1 Feb 2013). 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?
Areal Bone Density by DXA (time frame: 18-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 NCT00310791, which also lists 10 linked publications.
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 11 Apr 2018.