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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00670501




Registration number
NCT00670501
Ethics application status
Date submitted
29/04/2008
Date registered
1/05/2008
Date last updated
1/05/2008

Titles & IDs
Public title
Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
Scientific title
Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
Secondary ID [1] 0 0
B3D-MC-GHAC
Secondary ID [2] 0 0
547
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - teriparatide
Treatment: Drugs - teriparatide
Treatment: Drugs - Placebo
Treatment: Drugs - Calcium Supplement
Treatment: Drugs - Vitamin D Supplement

Experimental: 1 - LY333334 40 micrograms/day plus calcium and vitamin D

Experimental: 2 - LY333334 20 micrograms/day plus calcium and vitamin D

Placebo Comparator: 3 - Placebo plus calcium and vitamin D


Treatment: Drugs: teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

Treatment: Drugs: teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase

Treatment: Drugs: Placebo
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

Treatment: Drugs: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement

Treatment: Drugs: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Timepoint [1] 0 0
Baseline, randomization, 24 , 36, and 60 months
Secondary outcome [1] 0 0
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Timepoint [1] 0 0
Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
Secondary outcome [2] 0 0
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Timepoint [2] 0 0
Randomization, 12, 24, 36, 48 and 60 months
Secondary outcome [3] 0 0
To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Timepoint [3] 0 0
Baseline, randomization, 24 months, 60 months
Secondary outcome [4] 0 0
To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Timepoint [4] 0 0
As clinically needed throughout the trial
Secondary outcome [5] 0 0
To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Timepoint [5] 0 0
Randomization, 12, 24, 36, 48, and 60 months
Secondary outcome [6] 0 0
To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Timepoint [6] 0 0
Randomization, 12 and 24 months
Secondary outcome [7] 0 0
To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Timepoint [7] 0 0
Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
Secondary outcome [8] 0 0
To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Timepoint [8] 0 0
Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
Secondary outcome [9] 0 0
To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Timepoint [9] 0 0
Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
Secondary outcome [10] 0 0
To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Timepoint [10] 0 0
Randomization, 12, 24, 36, 48, and 60 months
Secondary outcome [11] 0 0
To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Timepoint [11] 0 0
Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months

Eligibility
Key inclusion criteria
- Ambulatory, postmenopausal women.

- A minimum of either one moderate or two mild atraumatic vertebral fractures, and a
minimum of seven evaluable nonfractured vertebrae.

- Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the
average bone mass for young, healthy women (T-score) only in patients with fewer than
two moderate fractures or in patients previously treated with therapeutic doses of
bisphosphonates or fluorides

- Normal or clinically nonsignificant abnormal laboratory values (serum calcium,
PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin
D must be between the lower limit of normal & 3 times the upper limit of normal at
baseline).
Minimum age
30 Years
Maximum age
85 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Fractures in areas of bone affected by diseases other than osteoporosis (for example,
cancer or Paget's disease).

- Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as
determined by the centralized x-ray quality assurance center (for example, severe
scoliosis or kyphosis).

- Current or recent (within 1 year prior to randomization) metabolic bone disorders
other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy,
osteomalacia, or any secondary causes of osteoporosis

- Current or recent (within 1 year prior to randomization) disease which affects bone
metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.

- Currently suspected carcinoma or history of carcinoma in the 5 years prior to
randomization.

- Nephrolithiasis or urolithiasis in the 2 years prior to randomization.

- Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel
disease, or malabsorption syndrome, or any indication of poor intestinal absorption of
calcium, such as the combination of a low urinary calcium excretion and an elevated
serum intact parathyroid hormone level.

- Poor medical or psychiatric risk for treatment with an investigational drug, in the
opinion of the investigator.

- Treatment with androgens or other anabolic steroids in the 6 months prior to
randomization.

- Treatment with calcitonins in the 2 months prior to randomization.

- Treatment with estrogen

- Treatment with progestins in the 3 calendar months prior to randomization, or for more
than 2 months in the 12 calendar months prior to randomization.

- Treatment with corticosteroids.

- Treatment with fluorides in the 6 months prior to randomization or for more than 60
days in the 24 months prior to randomization.

- Treatment with oral bisphosphonates in the 3 months prior to randomization or for more
than 60 days in the 24 months prior to randomization; treatment with intravenous
bisphosphonates in the 24 months prior to randomization.

- Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or
agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory
value at randomization must be between the lower limit of normal and three times the
upper limit of normal.

- Treatment with coumarins and indandione derivatives in the 3 months prior to
randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6
months prior to randomization.

- Treatment with calcium- or aluminum-containing antacids

- Treatment with any other drug known to affect bone metabolism in the 6 months prior to
randomization.

- Treatment with any investigational drug during the month prior to the calcium and
vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic
classes during the month prior to the calcium & vitamin D run-in phase.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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. - Nedlands
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Argentina
State/province [2] 0 0
Capital Federal
Country [3] 0 0
Austria
State/province [3] 0 0
Graz
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Denmark
State/province [7] 0 0
Aarhus
Country [8] 0 0
Finland
State/province [8] 0 0
Kuopio
Country [9] 0 0
Hungary
State/province [9] 0 0
Szeged
Country [10] 0 0
Israel
State/province [10] 0 0
Tel-Hashomer
Country [11] 0 0
Italy
State/province [11] 0 0
Arenzano
Country [12] 0 0
Netherlands
State/province [12] 0 0
Amsterdam
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
Norway
State/province [14] 0 0
Kristiansand
Country [15] 0 0
Poland
State/province [15] 0 0
Warszawa
Country [16] 0 0
Sweden
State/province [16] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to demonstrate a reduction in the proportion of new
vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment
with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and
vitamin D alone.
Trial website
https://clinicaltrials.gov/show/NCT00670501
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications