Comparative efficacy, safety, pharmacokinetic, and immunogenicity study of LY06006 and EU-Prolia in postmenopausal women with osteoporosis
- Conditions
- postmenopausal osteoporosis
- Registration Number
- JPRN-jRCT2031220657
- Lead Sponsor
- Dong Ying
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 45
1. Participant must sign an ICF, which includes compliance with the requirements and restrictions in the protocol.
2. Ambulatory postmenopausal woman at >= 60 to <= 90 years of age.
3. Diagnosed with osteoporosis, with absolute BMD consistent with a T-score of <= -2.5 and >= -4.0 at the lumbar spine (L1-L4 region) as measured by DXA.
4. Has at least two lumbar vertebrae in L1 L4 region and one hip evaluable by DXA for BMD measurement.
5. Body weight >= 50 kg and <= 90 kg
1. A history and/or presence of severe or more than two moderate vertebral fractures; or a history and/or presence of hip fracture or atypical femur fracture; or presence of any active healing fracture
2. BMD absolute value is consistent with a T-score < -4.0 at the total hip or femoral neck
3. Evidence of any of the following conditions:
- A history of bone disease, such as osteomalacia, osteopetrosis, Paget's disease, or osteogenesis imperfecta
- A history of metabolic or other endocrinologic diseases, such as Cushing's disease, hyperprolactinemia, acromegaly, or any gastrointestinal disorders associated with malabsorption (e.g. Crohn's disease and chronic pancreatitis)
- A history of chronic inflammatory diseases, sclerosis, osteophytosis, severe scoliosis, or other degenerative changes due to other co-morbidities
- A history or current hyper- or hypoparathyroidism
- Current uncontrolled hyper- or hypothyroidism
- Presence of hypocalcemia and/or vitamin D deficiency
- Other disease conditions where there is bone/joint involvement
- A history of bilateral hip replacement
4. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years before enrollment
5. Liver diseases:
- Cirrhosis of the liver
- Known history and/or active infection of hepatitis B and/or hepatitis C
- Inadequate hepatic function (ALT and/or AST >= 2 X ULN)
6. Severe renal disease (eGFR < 30 mL/min)
7. Oral/Dental conditions:
- Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw
- Active dental or jaw condition which requires oral surgery
- Invasive dental procedure planned during the study or within the past 6 months
- Non-healed dental or oral surgery
- Active periodontal disease
8. Administration of medications that can affect BMD
- Denosumab used at any time prior to Screening visit
- Administration of bisphosphonate as follows: 1) oral bisphosphonates at any dose used for > 3 years cumulatively at Screening visit; 2) oral bisphosphonates at any dose used within 1 year prior to Screening visit (if <= 3 years of use cumulatively); 3) intravenous bisphosphonate at any dose within 5 years prior to Screening visit
- PTH or PTH analogues at any dose within 2 years prior to Screening visit
- Systemic HRT (oral or transdermal estrogen), SERMs, tibolone, aromatase inhibitors, or calcitonin treatment within 1 year prior to Screening visit
- Calcitriol, alfacalcidol, or eldecalcitol within 3 months of the Screening visit
- Fluoride or strontium at any dose at any time prior to Screening visit
- Romosozumab or cathepsin K inhibitors received at any time prior to Screening visit
- Systemic glucocorticoids (>= 5 mg prednisone or equivalent per day for more than 10 days or cumulative >= 50 mg) within 3 months prior to Screening visit
- Other bone active drugs such as anticonvulsants, heparin, vitamin K etc. within 3 months prior to Screening visit
9. A history and/or presence of significant cardiac disease or ECG abnormalities, or other clinically significant medical conditions indicating significant risk for participating in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method