Osteoporosis MedDRA version: 14.0 Level: PT Classification code 10031282 Term: Osteoporosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: .
Product Name: LY2541546
Product Code: LY2541546
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: LY2541546
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Ambulatory, postmenopausal women between 45 and 85 years of age, inclusive. Postmenopausal is defined as: - At least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy (confirmed by operative note if without hysterectomy) or, - Spontaneous amenorrhea, that is not induced by a medical condition such as anorexia nervosa or by medications (such as oral contraceptives, hormones, gonadotropin-releasing hormone [GnRH], anti-estrogens, selective estrogen receptor modulator [SERMs], chemotherapy), for at least 12 months, or for at least 6 months with a serum follicle-stimulating hormone (FSH) level >40 mIU/mL and a negative pregnancy test, or, - Hysterectomy prior to menopause and at least 2 years prior to randomization; if =60 years old, both serum estradiol level 30 mIU/mL. [2] Have low BMD, defined as a T-score for lumbar spine of between –3.5 and -2.0, inclusive, based on the local DXA report as interpreted by the investigator. The method of determining T-score values will be based on regional standards. Three of 4 vertebrae, L1 through L4, must be evaluable for BMD scoring, as measured by DXA. [3] Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures. [4] Willing to receive study drug and take daily supplements (calcium and Vitamin D). [5] Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [6] Are investigator site personnel directly affiliated with this study and/or their immediate families. [7] Are Lilly employees. [8] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study [9] Have previously completed or withdrawn from this study or any other study investigating LY2541546. [10] Have received treatment with any of the following medications more recently than 3 months prior to screening:androgen, Calcitonin, SERMs, Tibolone [11] Recent initiation of hormone replacement therapy. [12] Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates. [13] Have received treatment with any oral bisphosphonate within the last year or within the last 3 years. The patient may be enrolled if, as assessed by the investigator, she has taken clinically insignificant amounts of oral bisphosphonate. [14] Have received therapeutic doses of systemic corticosteroids for more than 1 month during the 6 months prior to screening. [15] Have received therapeutic doses of fluorides (20 mg/day) for more than 3 months during the last 3 years, or for more than a total of 2 years, or any within the last 6 months. [16] Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <10 ng/mL (25 nmol/L) at the screening visit. [17] Have any known bone disorder other than low BMD or osteoporosis. [18] Have a history of osteoporotic fractures, such as a fracture occurring during the menopausal years, but also including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or DXA. In addition, if the patient is considered to have a high risk for fracture as assessed by the investigator, based for example on age and T-score, they should be excluded. [19] Have a history of Bell's palsy, other cranial nerve damage, or have a history of a temporomandibular joint disorder (TMJD). [20] Have any history of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin. [21] In the opinion of the investigator, the patient represents an unacceptable medical or psychiatric risk for treatment with an investigational drug. [22] Have known allergy to LY2541546, any of the diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody [23] History of excessive consumption of alcohol or abuse of drugs within the last year, as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the dose response of LY2541546 using BMD change from baseline, measured by dual energy x-ray absorptiometry (DXA) of the lumbar spine at 52 weeks, compared with placebo in PMP women with low BMD.;Secondary Objective: - To evaluate the overall safety and tolerability of LY2541546 following multiple subcutaneous (SC) administrations. - To evaluate dose(s) of LY2541546 that increase BMD from baseline, measured by DXA of the lumbar spine at 12 and 24 weeks, compared with placebo. - To evaluate dose(s) of LY2541546 that increase BMD from baseline, measured by DXA of the proximal femur and wrist, compared with placebo. - To evaluate the dose effect of LY2541546 on biochemical markers of bone metabolism, including bone-specific alkaline phosphatase (BSAP), serum type I collagen fragment (CTx), osteocalcin, and serum N-terminal extension propeptide of type I collagen (P1NP).;Primary end point(s): The primary endpoint is the change from baseline to endpoint (52 weeks) in BMD of the lumbar spine measured by DXA.;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to 12, 24, and 64 weeks in lumbar spine bone mineral density (BMD) Change from baseline to 24, 52 and 64 weeks in proximal femur bone mineral density (BMD) Change from baseline to 52 week endpoint in proximal femur and wrist bone mineral density (BMD) Change from baseline to 52 week endpoint in Bone-specific alkaline phosphatase (BSAP) Change from baseline to 52 week endpoint in Serum type I collagen fragment (CTx) Change from baseline to 52 week endpoint in Osteocalcin Change from baseline to 52 week endpoint in Serum N-terminal extension propeptide of type I collagen (P1NP) ;Timepoint(s) of evaluation of this end point: 12, 24, 52 and 64 weeks as described above | — |
Countries
Denmark, Estonia, Lithuania
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed