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A Study of LY2541546 in Women With Low Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT01144377
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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, participants 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 or disease Intervention/treatment Phase
Osteoporosis Drug: LY2541546 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 180 mg LY2541546 Q4W + Placebo

LY2541546: 180 milligrams (mg) administered subcutaneously every 4 weeks (Q4W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

Drug: LY2541546
Administered subcutaneously
Other Name: Blosozumab

Drug: Placebo
Administered subcutaneously

Experimental: 180 mg LY2541546 Q2W
LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Drug: LY2541546
Administered subcutaneously
Other Name: Blosozumab

Experimental: 270 mg LY2541546 Q2W
LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Drug: LY2541546
Administered subcutaneously
Other Name: Blosozumab

Experimental: 270 mg LY2541546 Q12W + Placebo

LY2541546: 270 milligrams (mg) administered subcutaneously every 12 weeks (Q12W) for 52 weeks.

Placebo: administered subcutaneously every alternate 2 weeks from the LY2541546 dose for 52 weeks.

Drug: LY2541546
Administered subcutaneously
Other Name: Blosozumab

Drug: Placebo
Administered subcutaneously

Placebo Comparator: Placebo Comparator Q2W
Placebo: administered subcutaneously every 2 weeks (Q2W) for 52 weeks.
Drug: Placebo
Administered subcutaneously




Primary Outcome Measures :
  1. Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: Baseline, 52 weeks ]

    Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

    Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate.



Secondary Outcome Measures :
  1. Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: Baseline, 12 weeks and 24 weeks and 64 weeks ]

    Lumbar spine bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

    Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline lumbar spine BMD as a covariate


  2. Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD) [ Time Frame: Baseline, 24 weeks and 52 weeks and 64 weeks ]

    Femoral neck and total hip bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) analysis of covariance.

    Factors in the model included treatment, time and the interaction of treatment by time as fixed effects, and baseline BMD as a covariate.


  3. Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD) [ Time Frame: Baseline, 52 weeks ]

    Total radius of the wrist bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DXA).

    Least squares (LS) mean values were determined using a 1-factor analysis of covariance model with treatment group as the main effect and baseline BMD as a covariate.


  4. Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP) [ Time Frame: Baseline, 52 weeks ]
  5. Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx) [ Time Frame: Baseline, 52 weeks ]
  6. Change From Baseline to 52 Week Endpoint in Osteocalcin [ Time Frame: Baseline, 52 weeks ]
  7. Change From Baseline to 52 Week Endpoint in Serum N-terminal Extension Propeptide of Type I Collagen (P1NP) [ Time Frame: Baseline, 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes 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 (grams/square centimeter [g/cm^2]) 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 cubic millimeters (mm^3).

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), selective estrogen receptor modulators (SERMs) (Raloxifene, Tamoxifen, Toremifene, Clomiphene), or 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 milligrams per 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 nanograms per milliliter (ng/mL) [23 nanomoles per liter (nmol/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, participants will receive a loading dose of Vitamin D (at a dose of approximately 100,000 international units (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 micromoles per liter (µmol/L) or >2.0 milligrams per deciliter (mg/dL), alanine transaminase [ALT/SGPT] >100 units per liter (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01144377     History of Changes
Other Study ID Numbers: 11953
I2M-MC-GSDB ( Other Identifier: Eli Lilly and Company )
First Posted: June 15, 2010    Key Record Dates
Results First Posted: December 4, 2017
Last Update Posted: December 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
osteoporosis

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