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Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid 2x5 mg | Experimental | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 |
|
| Zoledronic Acid 1x5 mg | Experimental | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 |
|
| Placebo | Placebo Comparator | Placebo given at randomization and Month 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic acid 5 mg intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline). | Baseline, Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline). | Baseline, Month 24 |
| Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For information regarding facilities, please contact the Central Contact | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21037195 | Derived | Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082. | |
| 20168099 |
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Eligible patients were stratified according to their duration of menopause (those less than 5 years from menopause were included in Stratum I, while those 5 or more years from menopause were included in Stratum II), and randomized equally to one of the three treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid 2x5 mg | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 |
| FG001 | Zoledronic Acid 1x5 mg | Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12 |
| FG002 | Placebo | Placebo given at randomization and Month 12 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stratum I |
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| |||||||||||||||||||||
| Stratum II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid 2x5 mg | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 |
| BG001 | Zoledronic Acid 1x5 mg | Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum | The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline). | Intent to treat population. Last observation carried forward (LOCF) was utilized to impute missing data. | Posted | Least Squares Mean | Standard Error | Percentage change in BMD | Baseline, Month 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid 2x5 mg | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Physiologic 0.9% normal saline |
|
The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline). |
| Baseline, Month 24 |
| Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 |
| Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 |
| Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum. | Months 6, 12, 18 and 24 |
| Derived |
| McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):999-1007. doi: 10.1097/AOG.0b013e3181bdce0a. |
| Withdrawal by Subject |
|
| Abnormal test procedure result (s) |
|
| NOT COMPLETED |
|
|
| BG002 | Placebo | Placebo given at randomization and Month 12 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Data presented for Overall number of Participants and Gender include participants from both strata of the study. | Count of Participants | Participants |
|
Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
| OG002 | Placebo | Placebo given at randomization and Month 12 |
|
|
| Secondary | Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum. | The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline). | Intent to treat population with available data. | Posted | Least Squares Mean | Standard Error | Percentage change in BMD | Baseline, Month 24 |
|
|
|
| Secondary | Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum. | The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline). | Intent to treat population with available data. | Posted | Least Squares Mean | Standard Error | Percentage change in BMD | Baseline, Month 24 |
|
|
|
| Secondary | Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum | Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum. | Intent to treat population with available data. | Posted | Mean | Standard Deviation | ng/mL | Months 6, 12, 18 and 24 |
|
|
|
| Secondary | Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum | Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum. | Intent to treat population with available data. | Posted | Mean | Standard Deviation | ng/mL | Months 6, 12, 18 and 24 |
|
|
|
| Secondary | Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum | Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum. | Intent to treat population with available data. | Posted | Mean | Standard Deviation | ng/mL | Months 6, 12, 18 and 24 |
|
|
|
| 21 |
| 198 |
| 177 |
| 198 |
| EG001 | Zoledronic Acid 1x5 mg | Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12 | 17 | 181 | 158 | 181 |
| EG002 | Placebo | Placebo given at randomization and Month 12 | 23 | 202 | 160 | 202 |
| Thyroid mass | Endocrine disorders | MedDRA | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Loose body in joint | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cardiac neoplasm unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neurilemmoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pleural mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Global amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder prolapse | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Endometrial metaplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Leriche syndrome | Vascular disorders | MedDRA | Systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D010024 | Osteoporosis |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Stratum II (Women >= 5 Years From Menopause) |
|
| Stratum II (Women >= 5 Years From Menopause) |
|
|
| Stratum I - Month 18 |
|
| Stratum I - Month 24 |
|
| Stratum II - Month 6 |
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| Stratum II - Month 12 |
|
| Stratum II - Month 18 |
|
| Stratum II - Month 24 |
|
|
| Stratum I - Month 18 |
|
| Stratum I - Month 24 |
|
| Stratum II - Month 6 |
|
| Stratum II - Month 12 |
|
| Stratum II - Month 18 |
|
| Stratum II - Month 24 |
|
|
| Stratum I - Month 18 |
|
| Stratum I - Month 24 |
|
| Stratum II - Month 6 |
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| Stratum II - Month 12 |
|
| Stratum II - Month 18 |
|
| Stratum II - Month 24 |
|