Kambouris, A.

Kleerekoper, M.

Moore, D. R.

Talpos, G. B.

English

Henry Ford Health System Scholarly Commons

Henry Ford Hospital Medical Journal Volume 31 Number 4 Article 19 12-1983 Management of Primary Hyperparathyroidism: Report on a Workshop G. B. Talpos M. Kleerekoper A. Kambouris D. R. Moore Follow this and additional works at: https://scholarlycommons.henryford.com/hfhmedjournal  Part of the Life Sciences Commons, Medical Specialties Commons, and the Public Health Commons Recommended Citation Talpos, G. B.; Kleerekoper, M.; Kambouris, A.; and Moore, D. R. (1983) "Management of Primary Hyperparathyroidism: Report on a Workshop," Henry Ford Hospital Medical Journal : Vol. 31 : No. 4 , 236-238. Available at: https://scholarlycommons.henryford.com/hfhmedjournal/vol31/iss4/19 This Article is brought to you for free and open access by Henry Ford Health System Scholarly Commons. It has been accepted for inclusion in Henry Ford Hospital Medical Journal by an authorized editor of Henry Ford Health System Scholarly Commons. Henry Ford Hosp Med J Vol 31, No 4,1983 Management of Primary Hyperparathyroidism: Report on a Workshop G.B. Talpos, MD,* M . Kleerekoper, MD, * * A. Kambouris, MD,* and D.R. Moore, M D * * fd. Note - This overview was originally presented at the International Symposium on Clinical Disorders of Bone and Mineral Metabolism, May 9-13, 1983. Earlier presentations and discussions at this Symposium left many questions unanswered about the optimal man-agement of patients with primary hyperparathyroidism (PHPT) in whom the hypercalcemia is minimal and in whom signs and symptoms directly referable to hyper-calcemia and/or HPT are lacking. Al though this condi-tion has often been referred to as "asymptomatic PHPT", this term has been deliberately excluded from this paper because many patients with mild HPT are not truly asymptomatic. Clinically, their symptoms cannot be readily recognized, unlike the symptoms of PHPT, and the clinician cannot predict which of the many com-plaints might be alleviated by "correct ive" surgery (1). With this in mind, a workshop was held to discuss a prospective study of the management of PHPT. Gener-ally, everyone agreed that the current literature on PHPT does not provide adequate answers about optimal man-agement of patients with mild PHPT. Few studies have addressed this issue, and only one is randomized and prospective (2). Although documentation exists that a skilled surgeon can correct hypercalcemia due to PHPT in more than 95% of patients (Wells, et al, pp. 152 ff.), little evidence exists that this is of short- or long-term benefit in mild diseases. In fact, there is a paucity of information about the benefits of surgery in patients with any degree of hypercalcemia (Posen, et al, pp. 154 ff.). Answers to many of these questions could be provided by a well-designed, prospective, randomized clinical trial to evaluate the benefits and risks of surgical and nonsurgical management of patients with PHPT. Some of the questions that could be addressed, as generated by the participants of the workshop, are given below. Patient's Questions • If I feel well now, how wil l I feel better after surgery? • How long before complications develop if I don't have surgery? • What will happen if I don't have surgery at all? Physician's Questions • What is the natural history of skeletal complications, and how is this history affected by surgery? • How does the cost of surgery compare to the cost of medical follow-up? • Are there factors present at the t ime of diagnosis that can predict the clinical course of the disease in an individual patient? • Do different forms of PHPT exist, and do these relate to the different secretory abnormalities (set-point change versus non-set-point change) or to different histologic abnormalities? • What is the success rate of surgery? • Are these complications reversible? • What constitutes cure? • Which surgeons should perform the initial parathyroidectomy? •Depar tment of Surgery. Henry Ford Hospital • •Depar tment of Internal Med ic ine , Henry Ford Hospita! Address reprint requests to Dr. Talpos, Department of Surgery, Henry Ford Hospital, 2799 W Grand Blvd, Detro i t , M l 48202. 236 P r i m a r y H y p e r p a r a t h y r o i d i s m • Which surgeons should perform fol low-up explorations? Serious concerns were raised about the feasibility of conduct ing such a trial. The best recognized, published prospective clinical trial of the management of PHPT was conducted at the Mayo Clinic (3). A principal inves-tigator of that tr ial, Donald Scholz, reported at the workshop that the single l imit ing factor to the conduct of their trial was inadequate funding. Another major diff iculty encountered was the waning enthusiasm of the patient's primary care physician through the neces-sarily long fo l low-up period. These concerns were echoed by many o f the participants. Without attempting to minimize these diff icult ies, it was agreed to proceed with the design of a clinical trial in order to better seek funding for such an undertaking. Discussion then concentrated on establishing a diag-nosis of PHPT in a cost-effective manner. Table I contains the minimal criteria required to confirm PHPT. It also contains the parameters used to exclude nonparathyroid causes of hypercalcemia, such as sarcoidosis, milk-alkali syndrome, and various types of malignancy. Although some investigators had different operational definit ions, those present agreed to incorporate these criteria as the min imum guidelines for the proposed trial. Data which had been collected could always be excluded if not relevant, but data which had not been collected could never be assessed. The next issue addressed by the workshop participants was to determine which patients with PHPT could be ethically randomized into different treatment categories. TABLE I Min ima l Criteria to Diagnose PHPT and Exclude Nonparathyroid Causes of Hypercalcemia History and Physical Examination • Serum calcium greater than or equal to two standard deviations above the mean on more than one occasion (calcium measure-ments can be either ionized or protein-corrected total serum calcium) • Mul t i -channel biochemical profi le • Complete blood count • Urinalysis • Chest radiograph • Serum and urine protein electrophoresis • Immunoreact ive PTH • 24-hour urine for calcium and creatinine • Intravenous pyelogram • T4, T3 if age greater than 70 TABLE II Condit ions Mandat ing Parathyroidectomy if Present at Any Time Signs and Symptoms • Renal lithiasis • Clinically evident bone disease • Pancreatitis • Recurrent peptic ulcer disease • Disabling "so f t " PHPT-associated symptoms • Distance f rom medical care, making fo l low-up unlikely • Intercurrent thyroid surgery Laboratory Investigations • Serum calcium greater than 13 mg /DL on one occasion, greater than 12 mg/DL on two occasions, or greater than 11.5 mg/DL on three occasions. • Urinary calcium greater than 400 mg/24 hours on 750 mg calcium diet for 48 hours • Metabol ic bone disease (bone mineral content greater than two standard deviations below the mean) • Renal insufficiency • Anemia less than 10 gm hemoglob in /DL Patients with any of several serious conditions associated with hypercalcemia would be immediately moved into the surgical treatment group. Providing these patients with the usual treatment for hypercalcemia from PHPT (i.e., surgery) should protect them from possible detr i-mental effects of the study. A list of the conditions that would mandate surgery is found in Table I I . Al though the major categories for randomization of appropriate patients were surgical and nonsurgical, interest was expressed in further subdividing the non-surgical category. This would allow inclusion of other treatments also discussed at the Symposium, such as cimetidine, propanolol , estrogen, and diphosphanates, in addition to asimpleobservation group (Bilezikian, pp. 159 ff.: Marcus, et al, pp. 162 ff.). The services ofa biosta-tistician would be used to construct the overall experi-mental design, and a determination would be made about the practicality of assessing the number of patients necessary to provide statistical significance with this increased number of treatment categories. The desirability of surgical input and especially stan-dardization of the surgical approach was briefly dis-cussed when it was announced that the American Asso-ciation of Endocrine Surgeons (AAES) was interested in supporting this study. The consensus of the workshop participants was to leave further deliberations in this area to the AAES. Cont inued communication with this surgi-cal organization was encouraged. 237 Talpos, Kleerekoper, Kambouris and Moore After four hours of discussion the workshop closed. A strong initiative was begun toevaluatecurrent treatment of PHPT, and a commitment was made to continue developing a protocol with which to seek proper fund-ing. Individuals interested in participating in the design of this study were invited to contact the authors. References 1. Coe F, Favus M . Does mild asymptomatic hyperparathyroidism require surgery? New Eng J Med 1980;302:224-5. 2. Larsson L, Toss G, Lennquist S, Tegler L, Til l ing. A preliminary report f rom a prospective study on mild hyperparathyroidism. Submitted for publ icat ion. 3. Scholz D, Purnell D. Asymptomatic primary hyperparathyroidism: A 10-year prospective study. Mayo Clin Prot 1981:56:473-8. 238 

Management of Primary Hyperparathyroidism: Report on a Workshop

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Management of Primary Hyperparathyroidism: Report on a Workshop

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