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Effects of alendronate and vitamin D in patients with normocalcemic primary hyperparathyroidism

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Abstract

Summary

No data on the pharmacological treatment of normocalcemic hyperparathyroidism (NPHPT) are available. We treated 30 NPHPT postmenopausal women with alendronate/cholecalciferol (treated group) or vitamin D alone (control group). Over 1 year, bone mineral density (BMD) increased significantly in treated group, but not in control group. Both treatments did not affect serum or urinary calcium.

Introduction

Normocalcemic primary hyperparathyroidism (NPHPT) is defined by normal serum calcium and consistently elevated PTH levels after ruling out the causes of secondary hyperparathyroidism. It is likely that subjects with NPHPT may develop kidney and bone disease. As no data on the pharmacological treatment of NPHPT are available, we aimed to investigate the effects of alendronate and cholecalciferol on both BMD and bone biochemical markers in postmenopausal women with NPHPT. Safety of vitamin D was evaluated as secondary endpoint.

Methods

The study was a prospective open label randomized trial comparing 15 postmenopausal women with NPHPT (PMW-NPHPT), treated with oral alendronate plus cholecalciferol (treated group) and 15 PMW-NPHPT treated only with cholecalciferol (control group). Blood samples were obtained at baseline and after 3, 6, and 12 months. Bone turnover markers (BTM) were measured at baseline, 3, and 6 months, respectively. BMD was assessed at baseline and after 12 months.

Results

After 1 year of treatment, BMD increased significantly at the lumbar, femoral neck, and hip level in the treated group, but not in the control group (p = 0.001). No differences were found between or within groups in serum calcium, PTH, and urinary calcium levels. BTM significantly decreased in the treated group but not in the control group, at 3 and 6 months (p < 0.001), respectively. No cases of hypercalcemia or hypercalciuria were detected during the study.

Conclusion

The results of this study indicate that alendronate/cholecalciferol increases BMD in postmenopausal women with NPHPT. Alendronate/cholecalciferol or vitamin D alone does not affect serum or urinary calcium.

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Acknowledgments

We acknowledge the “Tendi la mano-AIPOM Onlus” (an independent Italian non-profit association) which paid for the laboratory tests. We acknowledge Dr. Paul Christie for reviewing the manuscript.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Thyroid Diseases Center, Department of Internal Medicine, “S.M.Goretti” Hospital, Latina, Italy

    R. Cesareo

  2. Institute of Biochemistry and Clinical Biochemistry, University Cattolica del Sacro Cuore, Rome, Italy

    E. Di Stasio & F. Romitelli

  3. Department of Endocrinology and Metabolism, University-Hospital S. Maria della Misericordia, Udine, Italy

    F. Vescini & F. Grimaldi

  4. Department of Internal Medicine, “S.M.Goretti” Hospital, Latina, Italy

    G. Campagna

  5. Department of Radiology, “S.M.Goretti” Hospital, Latina, Italy

    R. Cianni & V. Pasqualini

  6. Department Endocrinology and Diabetes, University Campus Bio-Medico of Rome, Via Alvaro del Portillo, 21, 00128, Rome, Italy

    S. Manfrini & A. Palermo

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  1. R. Cesareo
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  10. A. Palermo
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Corresponding author

Correspondence to A. Palermo.

Additional information

Roberto Cesareo and Enrico Di Stasio contributed equally to this work.

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Cesareo, R., Di Stasio, E., Vescini, F. et al. Effects of alendronate and vitamin D in patients with normocalcemic primary hyperparathyroidism. Osteoporos Int 26, 1295–1302 (2015). https://doi.org/10.1007/s00198-014-3000-2

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