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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/08/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/1999
Sample size
Target
Accrual to date
Final
1637
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00670501