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This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zometa | Experimental | Zoledronic acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
|
| Placebo | Placebo Comparator | Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24 | Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. | baseline, month 24 |
| Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score | Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis. | baseline, month 24 |
| Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score | Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss. | baseline, month 24 |
| Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit | Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4) | baseline, month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24 | Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side) | baseline, month 24 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Marburg | 35043 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979716 | Derived | Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
| FG001 | Zometa | Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
| BG001 | Zometa | Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
| 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 | Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to Month 24 | Bone mineral density (BMD) by DXA at lumbar spine (L2-L4); DXA assessments of the BMD at dual hips. (BMD). Two X-ray beams with different energy levels are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | Z-score | baseline, month 24 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24 | Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side) | baseline, month 24 |
| Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS) | Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | baseline, month 24 |
| Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA) | Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | baseline, month 24 |
| Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS) | Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | baseline, month 24 |
| Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24 | CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption. | baseline, month 24 |
| Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24 | Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover | baseline, month 24 |
| Change in Estradiol (E2) From Baseline to Month 24 | Change in Estradiol from baseline to month 24 | baseline, month 24 |
| Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24 | Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24 | baseline, month 24 |
| Change in Testosterone From Baseline to Month 24 | Change in Testosterone from baseline to month 24 | baseline, month 24 |
| Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24 | Change in Sex Hormone binding globulin (SHGB) from baseline to month 24 | baseline, month 24 |
| Change in Parathyroid Hormone (PTH) From Baseline to Month 24 | Change in Parathyroid Hormone (PTH) from baseline to month 24 | baseline, month 24 |
| Change in Vitamine D From Baseline to Month 24 | Change in Vitamine D from baseline to month 24 | baseline, month 24 |
| Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24 | Change in anti-Mueller hormone (AMH) from baseline to month 24 | baseline, month 24 |
| Change in Inhibin A and Inhibin B From Baseline to Month 24 | Change in Inhibin A and Inhibin B from baseline to month 24 | baseline, month 24 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | All participants were females | Count of Participants | Participants |
|
| OG001 |
| Zometa |
Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions). |
|
|
| Primary | Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by T-score | Bone mineral density (BMD) at lumbar spine (L2-L4) by T-score. Your T-score is the number of units that your bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates that it is likely osteoporosis. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | T-score | baseline, month 24 |
|
|
|
| Primary | Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score | Bone mineral density (BMD) at lumbar spine (L2-L4) measured by Z-score. If Z-score is -2 or lower, it may suggest that something other than aging is causing abnormal bone loss. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | Z-score | baseline, month 24 |
|
|
|
| Primary | Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit | Bone mineral density (BMD) at lumbar spine (L2-L4) measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L2-L4) | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | percentage change | baseline, month 24 |
|
|
|
| Secondary | Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24 | Bone mineral density (BMD) for femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side) | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | Percentage Change | baseline, month 24 |
|
|
|
| Secondary | Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24 | Bone mineral density (BMD) for total femoral neck (right and left side) is measured by using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done on femoral neck (right and left side) | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | percentage change | baseline, month 24 |
|
|
|
| Secondary | Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS) | Bone mineral density (BMD) for Os calcis (right and left side) is measured by SOS; SOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | m/s | baseline, month 24 |
|
|
|
| Secondary | Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA) | Bone mineral density (BMD) for Os calcis (right and left side) is measured by BUA; BUA is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | dB/MHz | baseline, month 24 |
|
|
|
| Secondary | Change in Bone Mineral Density Phalanges II, III, IV, and V From Baseline to Month 24 or Last Visit as Measured by Amplitude-dependent Speed of Sound (ADSOS) | Bone mineral density (BMD) for Phalanges II, III, IV, and V is measured by ADSOS; ADSOS is a Quantitative ultrasonography scanning and measures bone mass and strength and assesses bone microarchitecture by detecting the transmission of high-frequency sound waves through bone. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | m/s | baseline, month 24 |
|
|
|
| Secondary | Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24 | CTX is a telopeptide that can be used as a biomarker in the serum to measure the rate of bone turnover. The test used to detect the CTX marker is specific to bone resorption. | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/mL | baseline, month 24 |
|
|
|
| Secondary | Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24 | Change in Aminoterminal propeptide on type I procollagen (P1NP) from baseline to month 24. P1NP is a marker for bone formation. It is a specific indicator of type 1 collagen deposition. P1NP is increased in states of high bone turnover | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Estradiol (E2) From Baseline to Month 24 | Change in Estradiol from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/L | baseline, month 24 |
|
|
|
| Secondary | Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24 | Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | mIU/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Testosterone From Baseline to Month 24 | Change in Testosterone from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24 | Change in Sex Hormone binding globulin (SHGB) from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | nmol/l | baseline, month 24 |
|
|
|
| Secondary | Change in Parathyroid Hormone (PTH) From Baseline to Month 24 | Change in Parathyroid Hormone (PTH) from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | pg/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Vitamine D From Baseline to Month 24 | Change in Vitamine D from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24 | Change in anti-Mueller hormone (AMH) from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | ng/ml | baseline, month 24 |
|
|
|
| Secondary | Change in Inhibin A and Inhibin B From Baseline to Month 24 | Change in Inhibin A and Inhibin B from baseline to month 24 | ITT -Intent-To-Treat Population which contains all patients of the Safety Population for whom at least one post-baseline assessment of bone mineral density is available. | Posted | Mean | Standard Deviation | pg/ml | baseline, month 24 |
|
|
|
| 3 |
| 36 |
| 36 |
| 36 |
| EG001 | Zometa | Zometa | 6 | 34 | 33 | 34 |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GASTROINTESTINAL OEDEMA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA | Systematic Assessment |
|
| FEBRILE INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| OSTEOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| ATAXIA | Nervous system disorders | MedDRA | Systematic Assessment |
|
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| ADENOIDECTOMY | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| HYSTERECTOMY | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| VISUAL IMPAIRMENT | Eye disorders | MedDRA | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA | Systematic Assessment |
|
| IMPAIRED HEALING | General disorders | MedDRA | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA | Systematic Assessment |
|
| MASTITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA | Systematic Assessment |
|
| VAGINAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| VULVOVAGINAL CANDIDIASIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| RADIATION SKIN INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| HYPOKALAEMIA | 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 |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MUSCULOSKELETAL STIFFNESS | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| MYALGIA | 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 |
|
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| MOVEMENT DISORDER | Nervous system disorders | MedDRA | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| URGE INCONTINENCE | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| MENOPAUSAL SYMPTOMS | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA | Systematic Assessment |
|
| LYMPHOEDEMA | Vascular disorders | MedDRA | Systematic Assessment |
|
| THROMBOSIS | 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 or disclosure of trial results in their entirety
| D017437 |
| Skin and Connective Tissue Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Phalanges IV (n=35, 33) |
|
| Phalanges V (n=35, 33) |
|