A Study to assess effectiveness and safety of Lupin’s Denosumab (IRO2201A/LUBT014) compared to Prolia®
- Conditions
- Health Condition 1: Q782- Osteopetrosis
- Registration Number
- CTRI/2023/09/057671
- Lead Sponsor
- upin Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 > 3 years 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 (= 5 mg prednisone equivalent per
day for = 10 days or a total cumulative dose of = 50 mg) 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, gonadotropinreleasing
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. Abnormal serum calcium (re-test and rescreening is permitted):
current hypocalcemia ( < 8.4 mg/dL).
12. 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).
13. History and/or presence of following bone conditions: bone
metastases, renal osteodystrophy, Paget’s disease, osteogenesis
imperfect, osteopetrosis, osteomyelitis, Pott’s disease
(tuberculosis of spine), Cushing’s syndrome.
14. Current or prior use of romosozumab or antisclerostin antibody.
15. Current hypoparathyroidism or hyperparathyroidism other than
clinically not significant secondary hyperparathyroidism as judged
by the investigator.
16. Major surgery within 8 weeks before screening or planned,
anticipated major surgery during the study.
17. 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.
18. History and/o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change from baseline in Bone Mineral Density (BMD) at the lumbar spine at Month 12. <br/ ><br>Note: L1-L4 region should be included.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method 1 Efficacy Endpoints <br/ ><br>Percent change from baseline in BMD at the lumbar spine at Month 6 <br/ ><br>Percent change from baseline in BMD at the total hip & femoral neck at Month 6 & Month 12. <br/ ><br>2 Safety Endpoint <br/ ><br>Number of patients with treatment emergent adverse events (TEAEs) & Serious adverse events (SAEs). <br/ ><br>3 Immunogenicity Endpoint <br/ ><br>Proportion of patients with treatment emergent anti-Denosumab antibodies (binding & neutralizing) at month 3, 6, 9, & 12. <br/ ><br>4 Pharmacokinetic Endpoint <br/ ><br>Descriptive (pharmacokinetic [PK]) assessment of Serum Denosumab concentration.Timepoint: 3, 6, 9 & 12 months