Bone DensityPhase 3NCT03292146
Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study
A Phase 3 study testing Denosumab 60 MG [Prolia] and Alendronate 70Mg Tab in people with Bone Density and Bone Loss, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Bone Density, Bone Loss, Anorexia Nervosa
- What is being tested?
- Denosumab 60 MG [Prolia] and Alendronate 70Mg Tab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 22 Jul 2021
- Phase
- Phase 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age 20-60 years, skeletally mature with closed epiphyses
- Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria
- BMD T-score < -1.0
- Normal serum 25-OH vitamin D (>30 ng/mL) and calcium levels
- For women of reproductive age, agree to use an effective contraceptive method. Highly effective methods of birth control include:
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- Combined (estrogen and progestogen) hormonal methods (pills, vaginal ring, or skin patch)
- Intrauterine device (IUD)
- Intraduterine hormonal-releasing system (IUS)
- Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion)
- Your male partner has had a vasectomy and testing shows there is no sperm in the semen
- Dental check up within the past year
Who cannot join
- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
- Subjects with a known esophageal disease cannot participate in the alendronate extension study
- Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives or other forms of estrogen administration. Bisphosphonates must have been discontinued for at least one year before participation
- Immunodeficiency or taking immunosuppressive therapy
- Serum potassium <3.0 meq/L
- Serum ALT >3 times upper limit of normal
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- eGFR of less than 30 ml/min
- Hypocalcemia
- Diabetes mellitus
- Active substance abuse, including alcohol
- History of malignancy
- Paget disease of bone
- Osteomalacia
- Osteonecrosis of the jaw (ONJ) or risk factor for ONJ, such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease, and current use of corticosteroids.
- Planned invasive dental procedure over the next 24 months.
- Known senstivity to any of the products or components to be administered during dosing or known sensitivity to mammalian cell derived drug products
- Sensitivity to calcium or vitamin D supplements
- Pregnant, planning to become pregnant with 7 months after the end of treatment and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.
- Being tested
- Denosumab 60 MG [Prolia], Placebo Injection, Alendronate 70Mg Tab
- Medical subject headings
- Bone Diseases, Metabolic, Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab 60 MG [Prolia]Drug
Denosumab 60mg injection at baseline and 6 months
Placebo InjectionDrug
Placebo Injection at baseline and 6 months
Alendronate 70Mg TabDrug
Alendronate 70mg PO weekly starting at Month 12 through 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Active Denosumab 60mg Injection | Experimental | Denosumab 60mg injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months. Receives: Drug: Denosumab 60 MG [Prolia]; Drug: Alendronate 70Mg Tab |
| Placebo | Placebo comparator | Placebo injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months. Receives: Drug: Placebo Injection; Drug: Alendronate 70Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
Measured: 12 months (Period 1)
Secondary outcomes (2)
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Measured: Baseline to 24 months
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Measured: 12 months to 24 months (Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start25 Oct 2017
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
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 Bone DensityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Karen K Miller, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292146
- Sponsor's protocol ID
- 2017P000529
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2017
- Last updated
- 4 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Denosumab on Bone Mineral Density, Markers of Bone Metabolism and Bone Microarchitecture in Women With Anorexia Nervosa: A Pilot Study
- ClinicalTrials.gov ID
- NCT03292146
- Acronym / sponsor ID
- 2017P000529
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is a randomized, double-blind, placebo-controlled clinical trial which aims to investigate the effect of denosumab on BMD in women with anorexia nervosa. The investigators hypothesize that 12 months of denosumab administration will result in an increase in bone mineral density, decrease in markers of bone resorption and improvement in bone microarchitecture in osteopenic women with anorexia nervosa compared with placebo.
An optional extension study will offer subjects 12-month administration of open-label alendronate (an oral bisphosphonate) after the initial 12 month administration of denosumab or placebo. We hypothesize that 12 months of denosumab followed by 12 months of open-label alendronate will result in a greater increase in BMD compared to 12 months of placebo followed by 12 months of open-label alendronate. Within the group of women who receive sequential therapy with 12 months of denosumab followed by 12 months of alendronate, we hypothesize that BMD will be maintained between 12 and 24 months while on alendronate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Denosumab 60mg Injection | Experimental | Drug: Denosumab 60 MG [Prolia], Drug: Alendronate 70Mg TabDenosumab 60mg injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months. |
| Placebo | Placebo comparator | Drug: Placebo Injection, Drug: Alendronate 70Mg TabPlacebo injection at baseline study visit and 6 month study visit. Alendronate 70mg PO weekly starting at Month 12 through 24 months. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female
- Age 20-60 years, skeletally mature with closed epiphyses
- Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic criteria
- BMD T-score < -1.0
- Normal serum 25-OH vitamin D (>30 ng/mL) and calcium levels
Key exclusion criteria (18 listed)
- Any disease known to affect bone, including untreated thyroid dysfunction, Cushing's or renal failure
- Subjects with a known esophageal disease cannot participate in the alendronate extension study
- Any medication known to affect bone metabolism within 3 months of the study, excluding oral contraceptives or other forms of estrogen administration. Bisphosphonates must have been discontinued for at least one year before participation
- Immunodeficiency or taking immunosuppressive therapy
- 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 |
|---|---|---|
| Denosumab 60 MG [Prolia]Denosumab 60mg injection at baseline and 6 months | Drug | Active Denosumab 60mg Injection |
| Placebo InjectionPlacebo Injection at baseline and 6 months | Drug | Placebo |
| Alendronate 70Mg TabAlendronate 70mg PO weekly starting at Month 12 through 24 months. | Drug | Active Denosumab 60mg Injection, Placebo |
Primary outcome
Postero-anterior (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA)
Time frame: 12 months (Period 1)
Postero-anterior (PA) lumbar spine bone mineral density was assessed by dual-energy x-ray absorptiometry (DXA). The DXA scanner used was a Hologic Horizon A (Hologic, Inc., Waltham, MA).
2 secondary outcomes
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Time frame: Baseline to 24 months
Percent Change Postero-anterior (PA) Lumbar Spine Bone Mineral Density by DXA
Time frame: 12 months to 24 months (Period 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Karen K Miller, 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 3 study testing Denosumab 60 MG [Prolia] and Alendronate 70Mg Tab in people with Bone Density 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 12 inclusion and 18 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 4 Nov 2025. 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 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?
Yes. Results are posted in the registry (first posted 12 Oct 2022). 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 (PA) Lumbar Spine Bone Mineral Density by Dual-energy X-ray Absorptiometry (DXA) (time frame: 12 months (Period 1)). 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 4 Nov 2025.