Evaluation of efficacy, safety and immunogenicity of Lupins Denosumab compared to Prolia in postmenopausal women with osteoporosis.
- Conditions
- Osteoporosis
- Registration Number
- JPRN-jRCT2031230117
- Lead Sponsor
- Sakine Michitoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 400
1. Postmenopausal women with osteoporosis. A woman is considered postmenopausal if she meets any of the following criteria:
Lack of menstrual period for at least 12 months prior to screening, for which there is no other pathological or physiological cause.
Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago.
(Serum follicle stimulating hormone [FSH] and serum estradiol level tests can be done at screening in case of uncertainty.)
2. Age >= 55 and <= 80 years at the time of informed consent.3. Absolute bone mineral density consistent with T-score <= -2.5 and >= 4.0 at the lumbar spine as measured by Dual-energy X-ray absorptiometry (DXA).
4. At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA.
5. Patients willing to provide written informed consent.
1.Body weight of=<45 kg and>=95 kg at screening.
2.Presence of one severe or more than two moderate vertebral fractures as determined by spine X-ray during the screening period.
3.Inadequate renal function at the screening defined as patient on dialysis or estimated glomerular filtration rate(eGFR)<30 mL/min.
4.Presence of clinically significant leukopenia,neutropenia,or anaemias judged by the investigator.
5.Prior denosumab and strontium or fluoride administration.
6.Ongoing and/or prior administration of the following medicines for osteoporosis:
a.Intravenous bisphosphonates:dose received within 5 years prior to screening.
b.Oral bisphosphonates used>3years cumulative use,and any dose within 12 months of screening.
c.Teriparatide or any parathyroid hormones(PTH)analogues:dose received within 6 weeks prior to screening.
d.Tibolone, oral, or topical(e.g.,transdermal,intravaginal)estrogen,selective estrogen receptor modulators(SERMs):dose received within 6 weeks prior to screening.
e.Calcitonin:dose received within 6 weeks prior to screening.
f.Active Vitamin D dose received within 2 weeks prior to screening.
7.Systemic glucocorticosteroids(>=5mg prednisone equivalent per day for>=10 days or a total cumulative dose of=>50mg)within the past 3 months before screening.
8.Other bone active drugs(i.e.,drugs affecting bone metabolism)including heparin,anti-epileptics(except for benzodiazepines and pregabalin),systemic ketoconazole,adrenocorticotrophic hormone(ACTH),lithium,protease inhibitors, gonadotropin-releasing hormone(GnRH)agonists,or anabolic steroids within the past 3 months prior to screening.
9.Receiving or has received any investigational drug(or is currently using an investigational device)within 3 months before receiving IMP,or at least 10 times the respective elimination half-life(whichever period is longer).
10.Abnormal serum calcium(re-test and rescreening is permitted):current hypocalcemia(< 8.4 mg/dL).
11.Vitamin D deficiency(25-hydroxy vitamin D levels cut-off at<12 ng/mL)at screening. (Vitamin D repletion/re-test and rescreening is permitted).
12.History and/or presence of following bone conditions:bone metastases,renal osteodystrophy,Pagets disease,osteogenesis imperfect,osteopetrosis,osteomyelitis,Potts disease(tuberculosis of spine),Cushings syndrome.
13.Current or prior use of romosozumab or antisclerostin antibody.
14.Current hypoparathyroidism or hyperparathyroidism other than clinically not significant secondary hyperparathyroidism as judged by the investigator.
15.Major surgery within 8 weeks before screening or planned, anticipated major surgery during the study.
16.History and/or presence of malignancy(except completely cured in situ cervical carcinoma or non-metastatic squamous or basal cell carcinoma of the skin).Patient with history of malignancy without recurrence for more than 5 years can be included.
17.History and/or presence of significant cardiac disease as judged by the investigator.
18.Known intolerance to or malabsorption of calcium or Vitamin D.
19.Known hypersensitivity of monoclonal antibodies or history of systemic hypersensitivity to any component of the IMPs.
20.Contraindications to denosumab therapy(e.g.,hypocalcaemia),or calcium or vitamin D supplementation before starting the IMP administration.
21.Known allergic reactions,hypersensitivity,or intolerance to denosumab or to any ingredients of the IMP,including latex allergy.
22.Patient with seropositivity for human immunodeficiency virus infect
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method