High Dose Vit D Musculoskeletal Symptoms & Bone Density in Anastrozole-Treated Breast Cancer With Marginal Vit D Status

NCT00263185 | Completed Early Phase 1

• 1 other identifier: 05-0498 / 201012921
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• To compare the effects of high dose vitamin D versus standard dose vitamin D on musculoskeletal pain in breast cancer patients receiving anastrozole when vitamin D levels are in the insufficient but not deficient range (10 to 29 ng/ml).

  6 months for randomized phase, 12 months for open-label phase

Secondary Outcomes (3)

• To evaluate the prevalence of vitamin D insufficiency/deficiency in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms versus those who are asymptomatic.

  6 months for randomized phase, 12 months for open-label phase

• To establish correlations between levels of vitamin D, the levels of PTH, the degree of bone loss and the severity of musculoskeletal symptoms.

  6 months

• To evaluate the effect of standard dose versus high dose Vitamin D replacement on bone density in post-menopausal women with a history of breast cancer who are treated with anastrozole and have musculoskeletal symptoms.

  6 months

Study Arms (3)

Active Treatment Group

EXPERIMENTAL

Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Vitamin 50,000 IU/wk x 8 weeks and then once a month for a total of 6 months.

Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate; Drug: Vitamin D

Control Group

PLACEBO COMPARATOR

Patients with baseline 25OH vitamin D level of 10-19 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 16 weeks and then once a month for a total of 6 months. Patients with baseline 25OH vitamin D level of 20-29 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily. * Placebo once per week x 8 weeks and then once a month for a total of 6 months.

Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate; Other: Placebo

Observational Group

OTHER

Patients with a baseline Vitamin D level below 10 ng/ml. * Calcium carbonate 1000 mg/day * Vitamin D 400 units daily.

Dietary Supplement: Vitamin D; Dietary Supplement: Calcium carbonate

Interventions

Vitamin D DIETARY_SUPPLEMENT

Active Treatment Group; Control Group; Observational Group

Calcium carbonate DIETARY_SUPPLEMENT

Active Treatment Group; Control Group; Observational Group

Placebo OTHER

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a diagnosis of hormone receptor positive invasive breast cancer (Stage I-IIIB) or ductal carcinoma in situ (DCIS)
• Postmenopausal status
• Completed at least 8 weeks of anastrozole as adjuvant therapy prior to study entry
• Completed systemic chemotherapy and radiation treatments when indicated
• Serum Calcium ≤ 10.3 mg/dL
• Patients with marginal 25 OH Vitamin D level (between 10 and 29 ng/ml) will be in the Randomized Group or Low 25 OH Vitamin D level (less than 10 ng/ml) will be in Observational Group
• hour urine Calcium excretion ≤ 250 mg/g (calculated by dividing 24 hour calcium by 24 hour creatinine)
• A history of generalized musculoskeletal pain with or without localized regions or discomfort that has developed or worsened since starting adjuvant aromatase inhibitor therapy

You may not qualify if:

• Known metastatic disease
• History of kidney stones
• History of active primary hyperparathyroidism
• History of Paget's disease of the bone
• History of severe arthritis, rheumatoid arthritis, or severe neuropathy
• Normal 25 OH Vitamin D level (≥ 30 ng/ml)
• Medical or psychiatric condition which may preclude protocol compliance

Sponsors & Collaborators

• Washington University School of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vitamin D; Calcium Carbonate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Antonella Rastelli, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: November 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)