| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Treatment of osteoporosis in postmenopausal women |
|
| E.1.1.1 | Medical condition in easily understood language |
| menopauza utáni oszteoporozis kezelésére |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 13.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10031285 |
| E.1.2 | Term | Osteoporosis postmenopausal |
| E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess if one or more of the TD-delivered teriparatide doses is not inferior to SQ-delivered teriparatide 20mcg /day based on mean percent change in BMD at 12 months. The primary variable is the percent change from baseline in lumbar spine BMD at 12 months. |
|
| E.2.2 | Secondary objectives of the trial |
• Evaluate differences between SQ and each TD dose in lumbar spine BMD at 6 months, as assessed by the Central Reader,
Evaluate differences between SQ and each TD and procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide (CTX) .
• Evaluate differences between SQ and each TD dose in C terminal propeptide (C1CP; converted to serum procollagen type 1 C propeptide [P1CP] for comparison to previous SQ studies).
• Determine the safety of TD-delivered teriparatide for a range of doses.
• Evaluate the population PKs of teriparatide and explore the relationship between teriparatide plasma concentrations and PD endpoints.
• Evaluate the immunogenic response to TD-administered teriparatide.
• Evaluate data collected from patients via questionnaire on ease of use of the TD and SQ delivery experiences.
This is a device related outcome
This is a device related outcome. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol Sample Banking Addendum 12Y-MC-GHFA(1) a Phase 2 Study for Transdermal Application of Teriparatide
Revised Protocol Addendum(1) dated 27-Aug-2009 |
|
| E.3 | Principal inclusion criteria |
Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Ambulatory, postmenopausal women aged 45 to 85 years inclusive at the time of entry into the trial, whose last menstrual period occurred at least 2 years prior to entry into the trial. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum follicle stimulating hormone (FSH) level of >30 IU/L and serum estradiol level of <20 pg/ml or <73 pmol/L.
[2] Centrally confirmed lumbar spine or femoral neck BMD T-score of ≤2.5 as measured by DXA. Absolute values should be used for assessing BMD and are as follows:
Skeletal Site BMD Absolute Value (g/cm2)
(T-score <-2.5)
Hologic Lunar
Lumbar Spine (L1-L4) <_0.772 <-0.872
Femoral Neck <_0.558 <_0.691
[3] Three of 4 vertebrae, L1 through L4, must be evaluable for BMD scoring, as measured by DXA.
[4] Free of severe or chronically disabling conditions other than osteoporosis (for example, uncontrolled diabetes or diabetes with significant renal, vascular, neurologic, or ophthalmic complications).
[5] Able to use a pen-type injection delivery system satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver who can meet daily with the patient and is willing to be trained on and use the pen-injector on a daily basis.
[6] Able to use the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver who can meet daily with the patient and is willing to be trained on and use the ViaDerm Teriparatide System on a daily basis.
[7] Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
[8] Able to be reached by telephone for follow-up contact between visits.
|
|
| E.4 | Principal exclusion criteria |
[1] Abnormal laboratory values for albumin and alkaline phosphatase (normal range as defined by the central laboratory), except for clinically insignificant values as determined by the investigator in conjunction with the Lilly physician.
[2] Laboratory values outside the ranges for the following:
Serum calcium 8.3 -10.6 mg/dL (conventional units)
2.07 - 2.64 mmol/L (SI units)
iPTH(1 84)b 11-72 pg/mL (conventional units)
1.2-7.6 pmol/L (SI units)
25 hydroxyvitamin D levels 20 to 61 ng/mL (conventional units)
50-153 pmol/mL (SI units)
a Ranges specified for adults ≥18 years of age.
b Range using the Centaur Method.
[3] 24-hour urine calcium higher than 300 mg/day.
[4] Abnormal thyroid function not corrected by therapy.
[5] Significantly impaired renal function. This is defined as:
- serum creatinine >2.0 mg/dL or 177 micromol/L; or
- measured or calculated creatinine clearance that, in the opinion of the investigator, indicates significant renal impairment.
[6] Significantly impaired hepatic function, defined as:
• single transaminase (alanine transaminase [ALT], aspartate transaminase [AST], or gamma-glutamyl transpeptidase [GGT]) greater than 3 times the upper limit of normal (ULN); or
total bilirubin greater than 2.0 mg/dL (34 micromol/L).
[7] History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
[8] History of malignant neoplasms in the 5 years prior to randomization,
[9] History of nephrolithiasis or urolithiasis in the 2 years prior to randomization.
[10] Use of a pacemaker.
[11] Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
[12] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to randomization, in the opinion of the investigator.
31 Prior participation in any other clinical trial studying or prior treatment with denosumab or strontium ranelate |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary variable is the percent change from baseline in lumbar spine BMD at 12 months |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
• Evaluate differences between SQ and each TD dose in lumbar spine BMD at 6 months, as assessed by the Central Reader.
• Evaluate differences between SQ and each TD dose in procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide (CTX).
• Evaluate differences between SQ and each TD dose in C terminal propeptide (C1CP; converted to serum procollagen type 1 C propeptide [P1CP] for comparison to previous SQ studies).
• Determine the safety of TD-delivered teriparatide for a range of doses.
• Evaluate the population PK of teriparatide and explore the relationship between teriparatide plasma concentrations and PD endpoints.
• Evaluate the immunogenic response to TD-administered teriparatide.
• Evaluate data collected from patients via questionnaire on ease of use of the TD and SQ delivery experiences. This is a device-related outcome.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Argentina |
| Estonia |
| Hungary |
| Mexico |
| Romania |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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