Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

Zoledronic acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).

Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).

Zoledronic acid

Placebo

Novartis Pharmaceuticals

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

The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

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.

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.

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.

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)

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)

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)

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.

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.

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.

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.

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

Change in Estradiol from baseline to month 24

Change in Follicle- Stimulating Hormone (FSH) from baseline to month 24

Change in Testosterone from baseline to month 24

Change in Sex Hormone binding globulin (SHGB) from baseline to month 24

Change in Parathyroid Hormone (PTH) from baseline to month 24

Change in Vitamine D from baseline to month 24

Change in anti-Mueller hormone (AMH) from baseline to month 24

Change in Inhibin A and Inhibin B from baseline to month 24

Zometa

Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).

Total

Age, Continuous

Sex: Female, Male

Study Director

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.

Change in Bone Mineral Density (BMD) Measured by Dual (Energy) X-ray Absorptiometry (DXA) at Lumbar Spine (L2-L4) From Baseline to 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

Change in Bone Mineral Density (BMD) at Lumbar Spine (L2-L4) From Baseline to Month 24 or Last Visit Measure by Z-score

Percent Change in Bone Mineral Density for L2-L4 From Baseline to Month 24 or Last Visit

femoral neck (right)

femoral neck (left)

Percentage Change in Bone Mineral Density for Femoral Neck (Right and Left Side) From Baseline to Month 24

Percentage Change in Bone Mineral Density for Total Femoral Neck (Right and Left Side) From Baseline to Month 24

Os calcis (right)

Os calcis (left)

Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Speed of Sound (SOS)

Change in Bone Mineral Density Os Calcis (Right and Left Side) From Baseline to Month 24 as Measured by Broadband Ultrasound Attenuation (BUA)

Phalanges II (n=35, 33)

Phalanges III (n=35, 33)

Phalanges IV (n=35, 33)

Phalanges V (n=35, 33)

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)

Change in Serum CTX-carboxy-terminal Collagen Crosslinks From Baseline to Month 24

Change in Aminoterminal Propeptide on Type I Procollagen (P1NP) From Baseline to Month 24

Change in Estradiol (E2) From Baseline to Month 24

Change in Follicle- Stimulating Hormone (FSH) From Baseline to Month 24

Change in Testosterone From Baseline to Month 24

Change in Sex Hormone Binding Globulin (SHGB) From Baseline to Month 24

Change in Parathyroid Hormone (PTH) From Baseline to Month 24

Change in Vitamine D From Baseline to Month 24

Change in Anti-Mueller Hormone (AMH) From Baseline to Month 24

Inhibin A (n=34,34)

Inhibin B (n=34,34)

Change in Inhibin A and Inhibin B From Baseline to Month 24

Overall Study

Pharmaceutical Solutions

Hormones

Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.

Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover.

This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.

This study is not recruiting patients in the United States.

A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment

Analysis was not completed as study was not adequately powered due to premature study termination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss	NCT00375505	Breast Cancer	Zoledronic acid Placebo	18 Years -	Novartis
The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss	NCT00375505	Breast Cancer	Zoledronic acid Placebo	18 Years -	Novartis
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss	NCT00333229	Primary Hormone...	Zoledronic Acid Placebo	18 Years -	Novartis
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss	NCT00333229	Primary Hormone...	Zoledronic Acid Placebo	18 Years -	Novartis

Spots Global Cancer Trial Database for cancer therapy induced bone loss