Anorexia NervosaNCT01406444
IGF-1 and Bone Loss in Women With Anorexia Nervosa
A study testing rhIGF-1 and Risedronate in people with Anorexia Nervosa and Osteopenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anorexia Nervosa, Osteopenia, Osteoporosis
- What is being tested?
- rhIGF-1 and Risedronate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2019
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- AN defined by DSM-IV diagnostic criteria, including weight less than 85% of ideal body weight (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of <18.5 kg/m2 with or without amenorrhea
- Oral contraceptive use prior to enrollment
- BMD T score < -1.0
- Normal FSH and TSH or free T4
- Normal serum 25-OH vitamin D (>20 ng/mL) and calcium levels
- Ongoing care from a primary care provider
- Agree to use barrier contraception
Who cannot join
- Any subject with contraindications to risedronate
- Any subject with binge-purge subtype of anorexia nervosa who vomits regularly as their form of purging (vs. those who use laxatives or diuretics) and who have significant periodontal disease, tooth erosion or an invasive dental or periodontal procedure within the previous three months.
- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
- Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives. Bisphosphonates must have been discontinued for at least one year before participation
- Serum potassium <3.0 meq/L
- Serum ALT >3 times upper limit of normal
Show all 12Show fewer
- eGFR of less than 30 ml/min
- Pregnant and/or breastfeeding
- Diabetes mellitus
- Active substance abuse, including alcohol
- History of malignancy
- Atraumatic fracture within the prior year
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.
- Conditions
- Anorexia Nervosa, Osteopenia, Osteoporosis
- Being tested
- rhIGF-1, Risedronate, Placebo
- Keywords
- Anorexia Nervosa, Osteopenia, Osteoporosis, Bone density
- Medical subject headings
- Anorexia Nervosa, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhIGF-1Drug
Also called Increlex
Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.
RisedronateDrug
Also called Actonel
Risedronate 35mg PO one time weekly
PlaceboDrug
Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly
| Study group | Role | What they receive |
|---|---|---|
| rhIGF-1 followed by Risedronate | Active comparator | Sequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly Receives: Drug: rhIGF-1; Drug: Risedronate |
| Risedronate | Active comparator | Risedronate 35mg PO once weekly for 12 months Receives: Drug: Risedronate |
| Placebo | Placebo comparator | Placebo for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postero-anterior Spine Bone Mineral Density by DXA
Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
Measured: 12 Months
Secondary outcomes (1)
Lateral Spine Bone Mineral Density by DXA
Lateral spine bone mineral density by dual-energy X-ray absorptiometry
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 posted1 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2019
- Study completionMay 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Anne Klibanski, MD, Principal investigator, Massachusetts General HospitalErinne Meenaghan, NP, Study chair, Massachusetts General HospitalKaren Miller, MD, Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406444
- Sponsor's protocol ID
- 2R01DK052625
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2011
- Last updated
- 17 Jul 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGF-1 and Bone Loss in Women With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01406444
- Acronym / sponsor ID
- 2R01DK052625
- Conditions
- Anorexia Nervosa, Osteopenia, Osteoporosis
- Keywords
- Anorexia Nervosa, Osteopenia, Osteoporosis, Bone density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Posted 17 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anorexia nervosa is an eating disorder that can cause thinning of the bones (a decrease in bone density). A significant decrease in bone density is called osteopenia or osteoporosis. Sometimes the loss of bone density can be severe enough to cause breaks and fractures of the bones. It is not known what causes the bones to thin in anorexia nervosa. Women who have this condition often have thin or weak bones that are more likely to break. They also have very low levels of a chemical called IGF-1 in their body. This chemical is very important for increasing bone growth in puberty and for maintaining healthy adult bones. The investigators would like to find out if giving rhIGF-1 followed by risedronate or risedronate alone can lead to an increase in bone formation, bone density, and bone strength in women with anorexia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rhIGF-1 followed by Risedronate | Active comparator | Drug: rhIGF-1, Drug: RisedronateSequential therapy with rhIGF-1 (started at a dose of 30 mcg/kg subcutaneous BID and titrated) for 6 months followed by 6 months of risedronate 35mg PO once weekly |
| Risedronate | Active comparator | Drug: RisedronateRisedronate 35mg PO once weekly for 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 12 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-45 years
- AN defined by DSM-IV diagnostic criteria, including weight less than 85% of ideal body weight (restricting or binge/purge type, BMI 15-17.5) OR meet criteria for sub-threshold AN, i.e., all DSM-IV criteria except that patients can have a BMI of <18.5 kg/m2 with or without amenorrhea
- Oral contraceptive use prior to enrollment
- BMD T score < -1.0
- Normal FSH and TSH or free T4
Key exclusion criteria (12 listed)
- Any subject with contraindications to risedronate
- Any subject with binge-purge subtype of anorexia nervosa who vomits regularly as their form of purging (vs. those who use laxatives or diuretics) and who have significant periodontal disease, tooth erosion or an invasive dental or periodontal procedure within the previous three months.
- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
- Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives. Bisphosphonates must have been discontinued for at least one year before participation
- Serum potassium <3.0 meq/L
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 |
|---|---|---|
| rhIGF-1Also: IncrelexStudy participants will be started at a dose of 30 mcg/kg BID and will be titrated. | Drug | rhIGF-1 followed by Risedronate |
| RisedronateAlso: ActonelRisedronate 35mg PO one time weekly | Drug | Risedronate, rhIGF-1 followed by Risedronate |
| PlaceboPlacebo injections 30 mcg/kg BID, Placebo tablet PO once weekly | Drug | Placebo |
Primary outcome
Postero-anterior Spine Bone Mineral Density by DXA
Time frame: 12 Months
Postero-anterior spine bone mineral density by dual-energy X-ray absorptiometry
1 secondary outcome
Lateral Spine Bone Mineral Density by DXA
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 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
Erinne Meenaghan, NP study chair
Massachusetts General Hospital
Karen Miller, MD study director
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 study testing rhIGF-1 and Risedronate 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 8 inclusion and 12 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 17 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2020). 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?
Postero-anterior Spine Bone Mineral Density by DXA (time frame: 12 Months). 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 17 Jul 2020.