NCT01144377

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 4, 2017

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

June 11, 2010

Results QC Date

September 27, 2017

Last Update Submit

September 9, 2019

Conditions

Osteoporosis

Keywords

osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 52 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD)

    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.

    Baseline, 52 weeks

Secondary Outcomes (7)

  • Change From Baseline to 12, 24, and 64 Weeks in Lumbar Spine Bone Mineral Density (BMD)

    Baseline, 12 weeks and 24 weeks and 64 weeks

  • Change From Baseline to 24, 52, and 64 Weeks in Proximal Femur Bone Mineral Density (BMD)

    Baseline, 24 weeks and 52 weeks and 64 weeks

  • Change From Baseline to 52 Week Endpoint in Wrist Bone Mineral Density (BMD)

    Baseline, 52 weeks

  • Change From Baseline to 52 Week Endpoint in Bone-specific Alkaline Phosphatase (BSAP)

    Baseline, 52 weeks

  • Change From Baseline to 52 Week Endpoint in Serum Type I Collagen Fragment (CTx)

    Baseline, 52 weeks

  • +2 more secondary outcomes

Study Arms (5)

180 mg LY2541546 Q4W + Placebo

EXPERIMENTAL

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: LY2541546Drug: Placebo

180 mg LY2541546 Q2W

EXPERIMENTAL

LY2541546: 180 milligrams (mg) administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

Drug: LY2541546

270 mg LY2541546 Q2W

EXPERIMENTAL

LY2541546: 270 milligrams (mg) LY2541546 administered subcutaneously every 2 weeks (Q2W) for 52 weeks.

Drug: LY2541546

270 mg LY2541546 Q12W + Placebo

EXPERIMENTAL

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: LY2541546Drug: Placebo

Placebo Comparator Q2W

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LY2541546DRUG

Administered subcutaneously

Also known as: Blosozumab
180 mg LY2541546 Q2W180 mg LY2541546 Q4W + Placebo270 mg LY2541546 Q12W + Placebo270 mg LY2541546 Q2W
PlaceboDRUG

Administered subcutaneously

180 mg LY2541546 Q4W + Placebo270 mg LY2541546 Q12W + PlaceboPlacebo Comparator Q2W

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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, 30501, United States

Location

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, 20817, United States

Location

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, 2650, Denmark

Location

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, 7100, Denmark

Location

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, 10128, Estonia

Location

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, 386-0493, Japan

Location

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, 166-0003, Japan

Location

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, 10323, Lithuania

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

blosozumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 15, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2012

Study Completion

February 1, 2013

Last Updated

September 17, 2019

Results First Posted

December 4, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

DK(2)US(2)ES(1)JP(2)LI(1)