A Phase 3 interventional study of Denosumab and Placebo in Osteoporosis and Systemic Mastocytosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Among 64 studies testing denosumab in Osteoporosis — 8 open to participants now, 11 under way, 2 of them phase 3. Denosumab · Osteoporosis.
Among the 64 studies testing denosumab in Osteoporosis, this one is the 51st largest by enrollment, is one of 5 that started in 2018, is one of 24 in phase 3, and was the 39th registered.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
Browse Osteoporosis studies →8 of the 64 studies testing denosumab in Osteoporosis are open now, in 8 countries. Recruiting first, the newest first:
National Taiwan University Hospital · Sites in Taiwan
Ages 50–80 · Women only
Qilu Pharmaceutical Co., Ltd. · Sites in China
Ages 50–85 · Women only
Aarhus University Hospital · Sites in Denmark
Ages 40+ · Women only
Chrissy Kistler · Sites in United States
Ages 65+
Wuhan Union Hospital, China · Sites in China
Ages 40+
By country, each count listing its studies:
Denosumab: first FDA approval 2010 (PROLIA), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 132 Osteoporosis studies recruiting now, 76 (58%) set no upper age limit and 20 (15%) stop at 75 or younger; 9 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
64 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 16 · Phase 3 25 · Phase 4 19
First in 2002; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Median enrollment 90 across the 64 interventional studies. Of the 45 that completed or were terminated, 32 (71%) have results posted.
This tab as a report to print or save as PDF → With an account.
30 of 64 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
11 studies in Osteoporosis by Assistance Publique - Hôpitaux de Paris: none open now, none under way, none of them phase 3. Of 10 finished, 0 (0%) have results posted.
Among the 11 studies in Osteoporosis by Assistance Publique - Hôpitaux de Paris, this one is one of 3 that started in 2018, is the only one in phase 3, and was the 8th registered.
Assistance Publique - Hôpitaux de Paris’s Osteoporosis studies by the year they started, since 2005.
6 of the studies testing denosumab in Osteoporosis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07062978Phase 3Qilu Pharmaceutical Co., Ltd.A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® | 2027-01 |
| NCT06332014AmgenEvaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China | 2027-01-23 |
| NCT04608630Australian and New Zealand Intensive Care Research CentreBone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults | 2027-02-28 |
| NCT04800367Columbia UniversityRomosozumab/Denosumab Study for Premenopausal IOP | 2027-03 |
| NCT07271771Aarhus University HospitalThe Effect of Denosumab on Muscle and Strength and Insulin Sensitivity | 2027-03-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 64 studies testing denosumab in Osteoporosis, from their registry updates:
Among Assistance Publique - Hôpitaux de Paris’s 11 in Osteoporosis:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The study is looking at the efficacy of subcutaneously administrated denosumab 60 mg every 6 months versus placebo after 3 years, by analyze of lumbar spine bone mineral density (BMD) in systemic mastocytosis.
Investigators hypothesize that use of denosumab subcutaneously in patients with osteoporosis related to systemic mastocytosis is effective and safe to improve bone mineral density and prevent new bone events, based on targeted specific RANKL secretion by mast cells and short half-life of denosumab.
Systemic mastocytosis (SM) represents a heterogenous group of disease characterized by abnormal proliferation of mast cells caused by activating mutations in c-Kit receptor; a tyrosine kinase family receptor present in mast cell that control cell proliferation. Prevalence of SM is estimated to 1/20 000 person. According to the World Health Organization (WHO) criteria (Johnson et al, 2009), SM can be separated into two different groups : indolent SM and aggressive SM.
Aggressive SM are defined by a poor prognostic disease either because of an important mast cell tumor mass as sarcoma mastocytosis or mast cell leukemia, or due to an association with an other myeloid hemopathy as myelodysplasic/myeloproliferative syndrome.
Indolent SM are the most common cases with a very good prognostic similar to general population. Symptoms related to mast cell proliferation in indolent SM are very various (Theoharides et al., 2015) and could be divided into 2 entities : those related to mast cell proliferation in tissue as the urticaria pigmentosa and those related to the mast cell degranulation.
There are many clinical relevant mediators released by mast cells after activation that could have putative effects on different systems as cardiovascular, cutaneous, neurologic, digestive, systemic, respiratory and musculoskeletal (Frenzel et al., 2013). Tryptase, histamine, prostaglandin, interleukine-6 and Tumor Necrosis Factor (TNF)-α are the most common and ubiquitous mediators released by mast cells but there are also some specific mediator targeting an organ as RANKL ; expression of RANKL by mast cells directly control regulation of osteoclast activity and is involved in osteoporosis associated to SM (Rabenhorst et al., 2013).
In systemic mastocytoses, bone lesions are found in about half of patients. A third have osteoporosis defined as a lumbar spine or hip bone T score of -2,5 Standard Deviation (SD) or less. In most cases, osteoporosis was complicated at least by one vertebral fracture with pain and functional disorders (Barete et al, 2010). The median time to fragility fracture after mastocytoses diagnosis is up to 5 years, even in very young population usually considering as low risk of fracture in non mastocytoses associated osteoporosis (Van de Veer et al., 2014)
By default, these patients are generally treated with bisphosphonate per os or intravenously with some efficiency on bone mineral density gain and bone turnover marker decrease (Rossini et al, 2014). However, no study with bisphosphonate in SM has showed durable prevention of new bone events and there are no randomized studies that proved their efficacy in systemic mastocytosis. Moreover, these drugs are not well tolerated in SM wether per os due to worsening of digestive symptoms by mast cells activation, or intravenously with an important number of acute phase characterized by some systemic symptoms as fever ; really experiences with intravenous biphosphonate but very increased in SM. Additional, the use of a bisphosphonate ask the question of the residual long-term effect of this drug that may be several years or even decades with a significant risk of atypical fracture secondary to a adynamic bone remodeling (Edwards et al. , 2013) and the long-term presence of crystals of bisphosphonate in the skeleton, particularly worrying in women of childbearing age. In postmenopausal osteoporosis, importance of residual long-term effect is weighted with advanced median age of patient. The fact that mostly patients with a systemic mastocytosis are young people led to restrict the use of bisphosphonate due to those effects.
Among different treatment available in post menopausal osteoporosis, the use of an anti-RANKL antibody, denosumab, in SM associated osteoporosis could be interesting. First, denosumab has already shown significant efficacy in the treatment of postmenopausal osteoporosis in women (Cummings et al , 2009). Second, this treatment is proposed every 6 months by a subcutaneous injection with very few side effects and half-life drug is shorter than biphosphonate with probably low residual long-time effect. Third, as mast cells expressed mainly RANKL with a direct role on bone turnover in SM. The use of a specific drug seems to be obvious and attractive.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient with:
(in case of osteoarthritis at the lumbar spine, the T score at left femoral neck or total left hip can be used to define osteoporosis or osteopenia)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Denosumab 60 mg subcutaneously injection with prefilled syringe
Drug: Denosumab
NaCl 0.9%, 20ml phial, solution for injection
Drug: Placebo
Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections
Also known as: XGeva®
Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections
Analysis of the lumbar spine bone mineral density (BMD)
Dual energy x-ray absorptiometry at lumbar spine (L2-L4)
Time frame: 3 years
Occurrence of a low energy vertebral fracture and non vertebral fracture
Lateral and front lumbar x-ray
Time frame: Baseline, 1 year, 2 years and 3 years
BMD at the total left hip
Dual energy x-ray absorptiometry at lumbar spine (L2-L4)
Time frame: Baseline, 3 years
BMD at lumbar spine and the total left hip
Dual energy x-ray absorptiometry at left femoral neck and total left hip
Time frame: Baseline, 1 year, 2 years
Biological assays with bone turnover marker of resorption and tryptase levels to assess mastocytosis activity
Withdrawal of 45 ml of blood
Time frame: Baseline, then every 6 months in 3 years
Number of serious adverse events to evaluate drug tolerance
* Biological assessment: complete blood count, creatinemia, electrolytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, c-reactive protein (CRP), phosphocalcic analyses with calcemia, phosphoremia, parathormone, vitamin D (25-OH-D), β-Human Chorionic Gonadotropin (HCG) (if needed) * Clinical assessment: blood pressure, pulse, weight, height, PS, temperature
Time frame: Every 6 months in 3 years
Number of non-serious adverse events to evaluate drug tolerance
* Biological assessment: complete blood count, creatinemia, electrolytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, c-reactive protein (CRP), phosphocalcic analyses with calcemia, phosphoremia, parathormone, vitamin D (25-OH-D), β-Human Chorionic Gonadotropin (HCG) (if needed) * Clinical assessment: blood pressure, pulse, weight, height, PS, temperature
Time frame: Every 6 months in 3 years
Annual variation of BMD in placebo group and number of low energy fracture compared to historical postmenopausal data
Dual energy x-ray absorptiometry at lumbar spine (L2-L4), left femoral neck and total left hip
Time frame: Baseline, 1 year, 2 years, 3 years
Plan to share: No
Ran from Mar 2018 to primary completion in Mar 2024, 72 months.
Of 45 phase 3 interventional studies under Osteoporosis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 57. This study's 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Denosumab
Assistance Publique - Hôpitaux de Paris →