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A Study of LY2541546 in Women With Low Bone Mineral Density

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01144377
First received: June 11, 2010
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

The primary objectives of this study include evaluating the dose response of LY2541546 using bone mineral density (BMD) change from baseline as compared to placebo, and evaluating the overall safety and tolerability of LY2541546 following multiple subcutaneous administrations in postmenopausal (PMP) women with low BMD. Following the last dose of study drug, participant's will be able to participate in a 12 month extension to collect additional safety and efficacy data (no further treatment will be administered during this extension).


Condition Intervention Phase
Osteoporosis
Drug: LY2541546
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized Study of LY2541546 Versus Placebo in Postmenopausal Women With Low Bone Mineral Density: An Evaluation of the Dose Response Relationship Using Bone Mineral Density

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 52 week endpoint in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 12, 24, and 64 weeks in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline, 12 weeks, 24 weeks, 64 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24, 52 and 64 weeks in proximal femur bone mineral density (BMD) [ Time Frame: Baseline, 24 weeks, 52 weeks, 64 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in proximal femur and wrist bone mineral density (BMD) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Bone-specific alkaline phosphatase (BSAP) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Serum type I collagen fragment (CTx) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Osteocalcin [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Serum N-terminal extension propeptide of type I collagen (P1NP) [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 153
Study Start Date: August 2010
Study Completion Date: February 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 180 mg LY2541546 given every 4 weeks
LY2541546 will be administered subcutaneously every 4 weeks with Placebo given every alternate 2 weeks (Patient will receive an injection every 2 weeks) for 52 weeks.
Drug: LY2541546
Administered subcutaneously
Drug: Placebo
Administered subcutaneously
Experimental: 180 mg LY2541546 given every 2 weeks
Administered subcutaneously for 52 weeks
Drug: LY2541546
Administered subcutaneously
Experimental: 270 mg LY2541546 given every 2 weeks
Administered subcutaneously for 52 weeks
Drug: LY2541546
Administered subcutaneously
Placebo Comparator: Placebo given every 2 weeks
Administered subcutaneously for 52 weeks
Drug: Placebo
Administered subcutaneously
Experimental: 270 mg LY2541546 given every 12 weeks
LY2541546 will be administered subcutaneously every 12 weeks with Placebo given every 2 weeks when LY2541546 is not administered (Patient will receive an injection every 2 weeks) for 52 weeks.
Drug: LY2541546
Administered subcutaneously
Drug: Placebo
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory, postmenopausal women, inclusive.
  • Have low bone mineral density (BMD), defined as a T-score, or equivalent BMD absolute value (g/cm2), for the lumbar spine of between -3.5 and -2.0, inclusive.
  • Without language barrier, reliable, and willing to make themselves available for the duration of the study and to follow study procedures.
  • Willing to take study drug and daily supplements (calcium and Vitamin D).
  • Normal laboratory tests or laboratory test results determined not clinically significant by the investigator. Serum phosphate and serum calcium must be within normal limits, and platelet level greater than 100,000 mm3.

Exclusion Criteria:

  • Have received treatment with any of the following medications more recently than 3 months prior to screening Androgen, Calcitonin, Estrogen (including over the counter preparations known to have estrogenic activity)*, Progestin (including over the counter preparations known to have progestogenic activity)*, SERMs (Raloxifene, Tamoxifen, Toremifene, Clomiphene), Tibolone
  • Have previously used or currently use denosumab, parathyroid hormone (PTH) and/or PTH analogs, strontium ranelate, or parenteral formulations of bisphosphonates.
  • Have received treatment with any oral bisphosphonate within the last year
  • Have received therapeutic doses of systemic corticosteroids for more than one month during the 6 months prior to screening.
  • 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.
  • Have severe Vitamin D deficiency defined as 25-hydroxyvitamin D less than <9.2 ng/mL (23nmol/L) at screening. If the serum 25-hydroxy-vitamin D level at screening is less than or equal to 9.2 ng/mL and <20 ng/mL, patients will receive a loading dose of Vitamin D (at a dose of approximately 100,000 IU given orally) prior to enrollment.
  • Have any known bone disorder other than low BMD or osteoporosis.
  • Have a history of osteoporotic fractures, including known prevalent vertebral fracture or evidence of prevalent vertebral fracture on screening spine X-ray or dual-energy x-ray absorptiometry (DXA), or are considered to be at high risk for fracture.
  • Presence of any abnormality (such as artifacts or osteophytes) that would confound DXA evaluation of lumbar vertebrae in the L-1 through L-4 region.
  • Have a history of Bell's palsy, other cranial nerve disorders, or have a history of Temporomandibular Joint and Muscle Disorders (TMJDs).
  • 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.
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of constituting a risk when taking the study medication or of interfering with the interpretation of data.
  • Have acute or chronic liver disease ([bilirubin >34 µmol/L or >2.0 mg/dL, alanine transaminase [ALT/SGPT] >100 U/L, or alkaline phosphatase >300 U/L).
  • Have impaired kidney function (serum creatinine >135 µmol/L or >2.0 mg/dL).
  • Have known allergy to LY2541546, any of diluents or excipients of LY2541546, or significant allergy to any other monoclonal antibody
  • History of excessive consumption of alcohol or abuse of drugs within the last year.
  • Have poor medical condition or psychiatric risks for treatment with an investigational drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144377

Locations
United States, Georgia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gainesville, Georgia, United States, 30501
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bethesda, Maryland, United States, 20817
Denmark
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hvidovre, Denmark, 2650
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vejle, Denmark, 7100
Estonia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tallinn, Estonia, 10128
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nagano, Japan, 386-0493
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tokyo, Japan, 166-0003
Lithuania
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vilnius, Lithuania, 10323
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01144377     History of Changes
Other Study ID Numbers: 11953, I2M-MC-GSDB
Study First Received: June 11, 2010
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Denmark: Ethics Committee
Estonia: The State Agency of Medicine
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Japan: Institutional Review Board

Keywords provided by Eli Lilly and Company:
osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 27, 2014